Establishments and listings

Alinity i HSV-2 IgG Calibrator (LN 04W2102), Alinity i HSV-2 IgG Reagent Kit (LN 04W2127, 04W2137) +1

ABBOTT IRELAND · SLIGO, IE

Develop Specifications But Do Not Manufacture At This FacilityReg. 3008344661LGCMYF
K number
K243575
Proprietary name
Alinity i HSV-2 IgG Calibrator (LN 04W2102), Alinity i HSV-2 IgG Reagent Kit (LN 04W2127, 04W2137), Alinity i HSV-2 IgG Controls (LN 04W2112)
Establishment type
Develop Specifications But Do Not Manufacture At This Facility
Registration
Registration number
3008344661
FEI number
3008344661
Status code
1
Initial importer flag
N
Reg expiry date year
2027
Name
ABBOTT IRELAND
Address line 1
DIAGNOSTICS DIVISION
Address line 2
FINISKLIN BUSINESS PARK
City
SLIGO
Iso country code
IE
Postal code
-
US agent
Name
Sara Qadri
Business name
ABBOTT LABORATORIES
Bus phone area code
224
Bus phone num
6680142
Email address
sara.qadri@abbott.com
Address line 1
675 N Field Dr
Address line 2
Dept C2D8 Bldg CP01 Floor-3
City
Lake Forest
State code
IL
Iso country code
US
Zip code
60045
Owner operator
Firm name
ABBOTT LABORATORIES
Owner operator number
1415939
Contact address
Address 1
100 ABBOTT PARK RD.
Address 2
D-03Q3, AP52-1
City
Abbott Park
State code
IL
Iso country code
US
Postal code
60064
Products
  1. Product code
    LGC
    Created date
    2025-08-27
    Owner operator number
    1415939
    Harmonized identifiers (openFDA)
    Device name
    Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
    Medical specialty description
    Microbiology
    Regulation number
    866.3305
    Device class
    2
  2. Product code
    MYF
    Created date
    2025-08-27
    Owner operator number
    1415939
    Harmonized identifiers (openFDA)
    Device name
    Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
    Medical specialty description
    Microbiology
    Regulation number
    866.3305
    Device class
    2
    K number
    K243575
Establishments and listings

SARS-CoV-2 IgG Calibrator Kit (ARCHITECT, LN 6R86-01), SARS-CoV-2 IgG Control Kit (Alinity i, LN 06R9010) +16

ABBOTT IRELAND · SLIGO, IE

Manufacture Medical DeviceReg. 3008344661QKO
Proprietary name
SARS-CoV-2 IgG Calibrator Kit (ARCHITECT, LN 6R86-01), SARS-CoV-2 IgG Control Kit (Alinity i, LN 06R9010), SARS-CoV-2 IgG Calibrator Kit (Alinity i, LN 06R9001), SARS-CoV-2 IgG Reagent Kit (Alinity i, LN 06R9020, 06R9030), AdviseDx SARS-CoV-2 IgM Control Kit (Alinity i, LN 06R9110), AdviseDx SARS-CoV-2 IgM Reagent Kit (ARCHITECT, LN 06R8720, 06R8730), AdviseDx SARS-CoV-2 IgM Control Kit (ARCHITECT, LN 06R8710), AdviseDx SARS-CoV-2 IgM Calibrator Kit (ARCHITECT, LN 06R8701), AdviseDx SARS-CoV-2 IgG II (ARCHITECT, LN 6S60-20, 6S60-30), AdviseDx SARS-CoV-2 IgG II Calibrator Kit (Alinity i, LN 06S6101), AdviseDx SARS-CoV-2 IgG II Control Kit (Alinity i, LN 06S6110), SARS-CoV-2-IgG Reagent Kit (ARCHITECT, LN 6R86-20, 6R86-30), AdviseDx SARS-CoV-2 IgG II Calibrator Kit (ARCHITECT, LN 6S60-01), SARS-CoV-2 IgG Control Kit (ARCHITECT, LN 6R86-10), AdviseDx SARS-CoV-2 IgM Reagent Kit (Alinity i, LN 06R9120, 06R9130), AdviseDx SARS-CoV-2 IgM Calibrator Kit (Alinity i, LN 06R9101), AdviseDx SARS-CoV-2 IgG II Control Kit (ARCHITECT, LN 6S60-10), AdviseDx SARS-CoV-2 IgG II (Alinity i, LN 06S6120, 06S6130)
Establishment type
Manufacture Medical Device
Registration
Registration number
3008344661
FEI number
3008344661
Status code
1
Initial importer flag
N
Reg expiry date year
2027
Name
ABBOTT IRELAND
Address line 1
DIAGNOSTICS DIVISION
Address line 2
FINISKLIN BUSINESS PARK
City
SLIGO
Iso country code
IE
Postal code
-
US agent
Name
Sara Qadri
Business name
ABBOTT LABORATORIES
Bus phone area code
224
Bus phone num
6680142
Email address
sara.qadri@abbott.com
Address line 1
675 N Field Dr
Address line 2
Dept C2D8 Bldg CP01 Floor-3
City
Lake Forest
State code
IL
Iso country code
US
Zip code
60045
Owner operator
Firm name
ABBOTT LABORATORIES
Owner operator number
1415939
Contact address
Address 1
100 ABBOTT PARK RD.
Address 2
D-03Q3, AP52-1
City
Abbott Park
State code
IL
Iso country code
US
Postal code
60064
Products
  1. Product code
    QKO
    Created date
    2020-04-16
    Owner operator number
    1415939
    Harmonized identifiers (openFDA)
    Device name
    Reagent, Coronavirus Serological
    Medical specialty description
    Unknown
    Device class
    N
Establishments and listings

UCH-L1 Reagent Kit (Alinity i, LN 04W1922), GFAP Reagent Kit (Alinity i, LN 04W1722)

ABBOTT IRELAND · SLIGO, IE

Manufacture Medical DeviceReg. 3008344661QAT
K number
K223602
Proprietary name
UCH-L1 Reagent Kit (Alinity i, LN 04W1922), GFAP Reagent Kit (Alinity i, LN 04W1722)
Establishment type
Manufacture Medical Device
Registration
Registration number
3008344661
FEI number
3008344661
Status code
1
Initial importer flag
N
Reg expiry date year
2027
Name
ABBOTT IRELAND
Address line 1
DIAGNOSTICS DIVISION
Address line 2
FINISKLIN BUSINESS PARK
City
SLIGO
Iso country code
IE
Postal code
-
US agent
Name
Sara Qadri
Business name
ABBOTT LABORATORIES
Bus phone area code
224
Bus phone num
6680142
Email address
sara.qadri@abbott.com
Address line 1
675 N Field Dr
Address line 2
Dept C2D8 Bldg CP01 Floor-3
City
Lake Forest
State code
IL
Iso country code
US
Zip code
60045
Owner operator
Firm name
ABBOTT LABORATORIES
Owner operator number
1415939
Contact address
Address 1
100 ABBOTT PARK RD.
Address 2
D-03Q3, AP52-1
City
Abbott Park
State code
IL
Iso country code
US
Postal code
60064
Products
  1. Product code
    QAT
    Created date
    2023-05-30
    Owner operator number
    1415939
    Harmonized identifiers (openFDA)
    Device name
    Brain Trauma Assessment Test
    Medical specialty description
    Immunology
    Regulation number
    866.5830
    Device class
    2
    K number
    K223602
Establishments and listings

Cystatin C Controls (LN 06T3210), Alinity i Progesterone Controls (LN 08P3610) +50

ABBOTT IRELAND · SLIGO, IE

Manufacture Medical DeviceReg. 3008344661JJX
Proprietary name
Cystatin C Controls (LN 06T3210), Alinity i Progesterone Controls (LN 08P3610), Alinity i TSH Controls (LN 07P4810), Alinity i Total T4 Controls (LN 07P9510), Alinity i 2nd Generation Testosterone Controls (LN 07P6810), Alinity i Intact PTH Controls (LN 08P3111), Alinity i 25-OH Vitamin D Controls (LN 08P4512), Alinity i Total B-HCG Controls (LN 07P5110), Alinity i Folate Controls (LN 08P1412), Alinity i Prolactin Controls (LN 07P6610), Alinity i FSH Controls (LN 07P4910), FreeStyle Control Solution, Alinity i Estradiol Controls (LN 07P5010), Alinity i CA 15-3 Controls (LN 08P5110), Alinity i T-Uptake Controls (LN 08P1210), Alinity i C-Peptide Controls (LN 09P3610), Alinity i Anti-TPO Controls (LN 09P3510), Alinity i Free T4 Controls (LN 7P7010), ARCHITECT STAT High Sensitivity Troponin-I Controls (LN 2R98-10), Alinity c Hemoglobin A1c Controls (LN 08P4310), Alinity i DHEA-S Controls (LN 09P3710), Alinity i CA 125 II Controls (LN 08P4910), Alinity i B12 Controls (LN 07P6712), Alinity c ASO Control I (LN 04S0912), Alinity i Anti-Tg Controls (LN 09P3410), Alinity i Syphilis TP Controls (LN 07P6010), Alinity i Homocysteine Controls (LN 09P2810), Alinity c Cannabinoids Control 2 Kit (LN 09P5411), Lipase NG OC Control 1 (LN 04Y8510), Alinity i HE4 Controls (LN 08P5010), Alinity c Lp(a) Control Kit (LN 01R1410), Alinity c Cannabinoids Control 1 Kit (LN 09P5410), Alinity i Ferritin Controls (LN 07P6510), Alinity c Ammonia Controls (LN 08P2210), ARCHITECT Insulin Controls (LN 08K4112), Alinity i Insulin Controls (LN 04T7510), Lipase NG OC Control 2 (LN 04Y8511), Alinity i Active-B12 (Holotranscobalamin) Controls (LN 09P2610), Alinity c ASO Control II (LN 04S0913), Alinity i CA 19-9XR Controls (LN 08P3210) +12 more
Establishment type
Manufacture Medical Device
Registration
Registration number
3008344661
FEI number
3008344661
Status code
1
Initial importer flag
N
Reg expiry date year
2027
Name
ABBOTT IRELAND
Address line 1
DIAGNOSTICS DIVISION
Address line 2
FINISKLIN BUSINESS PARK
City
SLIGO
Iso country code
IE
Postal code
-
US agent
Name
Sara Qadri
Business name
ABBOTT LABORATORIES
Bus phone area code
224
Bus phone num
6680142
Email address
sara.qadri@abbott.com
Address line 1
675 N Field Dr
Address line 2
Dept C2D8 Bldg CP01 Floor-3
City
Lake Forest
State code
IL
Iso country code
US
Zip code
60045
Owner operator
Firm name
ABBOTT LABORATORIES
Owner operator number
1415939
Contact address
Address 1
100 ABBOTT PARK RD.
Address 2
D-03Q3, AP52-1
City
Abbott Park
State code
IL
Iso country code
US
Postal code
60064
Products
  1. Product code
    JJX
    Created date
    2017-11-22
    Owner operator number
    1415939
    Harmonized identifiers (openFDA)
    Device name
    Single (Specified) Analyte Controls (Assayed And Unassayed)
    Medical specialty description
    Clinical Chemistry
    Regulation number
    862.1660
    Device class
    1
Establishments and listings

Alinity i System Accessories, Alinity i Total B-hCG Reagent Kit (LN 07P5121, 07P5131) +2

ABBOTT IRELAND · SLIGO, IE

Manufacture Medical DeviceReg. 3008344661JJEDHA
K number
K170317
Proprietary name
Alinity i System Accessories, Alinity i Total B-hCG Reagent Kit (LN 07P5121, 07P5131), Alinity i System, Alinity i Refurbished Processing Module (LN 03R65-84)
Establishment type
Manufacture Medical Device
Registration
Registration number
3008344661
FEI number
3008344661
Status code
1
Initial importer flag
N
Reg expiry date year
2027
Name
ABBOTT IRELAND
Address line 1
DIAGNOSTICS DIVISION
Address line 2
FINISKLIN BUSINESS PARK
City
SLIGO
Iso country code
IE
Postal code
-
US agent
Name
Sara Qadri
Business name
ABBOTT LABORATORIES
Bus phone area code
224
Bus phone num
6680142
Email address
sara.qadri@abbott.com
Address line 1
675 N Field Dr
Address line 2
Dept C2D8 Bldg CP01 Floor-3
City
Lake Forest
State code
IL
Iso country code
US
Zip code
60045
Owner operator
Firm name
ABBOTT LABORATORIES
Owner operator number
1415939
Contact address
Address 1
100 ABBOTT PARK RD.
Address 2
D-03Q3, AP52-1
City
Abbott Park
State code
IL
Iso country code
US
Postal code
60064
Products
  1. Product code
    JJE
    Created date
    2018-05-03
    Owner operator number
    1415939
    Harmonized identifiers (openFDA)
    Device name
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
    Medical specialty description
    Clinical Chemistry
    Regulation number
    862.2160
    Device class
    1
  2. Product code
    DHA
    Created date
    2018-05-03
    Owner operator number
    1415939
    Harmonized identifiers (openFDA)
    Device name
    System, Test, Human Chorionic Gonadotropin
    Medical specialty description
    Clinical Chemistry
    Regulation number
    862.1155
    Device class
    2
    K number
    K170317
Establishments and listings

ARCHITECT HBsAg Qualitative Calibrators (LN 4P53-01), ARCHITECT HBsAg Qualitative Controls (LN 4P53-10) +8

ABBOTT IRELAND · SLIGO, IE

Manufacture Medical DeviceReg. 3008344661LOM
PMA number
P110029
Proprietary name
ARCHITECT HBsAg Qualitative Calibrators (LN 4P53-01), ARCHITECT HBsAg Qualitative Controls (LN 4P53-10), Alinity i HBsAg Qualitative II Confirmatory Reagent Kit (LN 08P1121), Alinity i HBsAg Qualitative II Confirmatory Manual Diluent (LN 08P1141), ARCHITECT HBsAg Qualitative Reagent Kit (LN 4P53-25, 4P53-35), Alinity i HBsAg Qualitative II Reagent Kit (LN 08P1021, 08P1031), ARCHITECT HBsAg Qualitative Confirmatory Reagent Kit (LN 4P54-25), Alinity i HBsAg Qualitative II Calibrators (LN 08P1002), Alinity i HBsAg Qualitative II Controls (LN 08P1012), ARCHITECT HBsAg Qualitative Confirmatory Manual Diluent (LN 4P54-40)
Establishment type
Manufacture Medical Device
Registration
Registration number
3008344661
FEI number
3008344661
Status code
1
Initial importer flag
N
Reg expiry date year
2027
Name
ABBOTT IRELAND
Address line 1
DIAGNOSTICS DIVISION
Address line 2
FINISKLIN BUSINESS PARK
City
SLIGO
Iso country code
IE
Postal code
-
US agent
Name
Sara Qadri
Business name
ABBOTT LABORATORIES
Bus phone area code
224
Bus phone num
6680142
Email address
sara.qadri@abbott.com
Address line 1
675 N Field Dr
Address line 2
Dept C2D8 Bldg CP01 Floor-3
City
Lake Forest
State code
IL
Iso country code
US
Zip code
60045
Owner operator
Firm name
ABBOTT LABORATORIES
Owner operator number
1415939
Contact address
Address 1
100 ABBOTT PARK RD.
Address 2
D-03Q3, AP52-1
City
Abbott Park
State code
IL
Iso country code
US
Postal code
60064
Products
  1. Product code
    LOM
    Created date
    2012-05-16
    Owner operator number
    1415939
    Harmonized identifiers (openFDA)
    Device name
    Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
    Medical specialty description
    Microbiology
    Regulation number
    866.3172
    Device class
    2
Establishments and listings

Alinity s System Accessories, Alinity s System

ABBOTT IRELAND · SLIGO, IE

Manufacture Medical DeviceReg. 3008344661MZA
Proprietary name
Alinity s System Accessories, Alinity s System
Establishment type
Manufacture Medical Device
Registration
Registration number
3008344661
FEI number
3008344661
Status code
1
Initial importer flag
N
Reg expiry date year
2027
Name
ABBOTT IRELAND
Address line 1
DIAGNOSTICS DIVISION
Address line 2
FINISKLIN BUSINESS PARK
City
SLIGO
Iso country code
IE
Postal code
-
US agent
Name
Sara Qadri
Business name
ABBOTT LABORATORIES
Bus phone area code
224
Bus phone num
6680142
Email address
sara.qadri@abbott.com
Address line 1
675 N Field Dr
Address line 2
Dept C2D8 Bldg CP01 Floor-3
City
Lake Forest
State code
IL
Iso country code
US
Zip code
60045
Owner operator
Firm name
ABBOTT LABORATORIES
Owner operator number
1415939
Contact address
Address 1
100 ABBOTT PARK RD.
Address 2
D-03Q3, AP52-1
City
Abbott Park
State code
IL
Iso country code
US
Postal code
60064
Products
  1. Product code
    MZA
    Created date
    2016-12-15
    Owner operator number
    1415939
    Harmonized identifiers (openFDA)
    Device name
    Test, Equipment, Automated Bloodborne Pathogen
    Medical specialty description
    Unknown
    Device class
    N
Establishments and listings

ARCHITECT STAT Myoglobin Reagent Kit (LN 2K43-20, 2K43-25), Alinity i STAT Myoglobin Reagent Kit (LN 04V3720, 04V3730) +1

ABBOTT IRELAND · SLIGO, IE

Repack or Relabel Medical DeviceReg. 3008344661DDRJIS
K number
K042924
Proprietary name
ARCHITECT STAT Myoglobin Reagent Kit (LN 2K43-20, 2K43-25), Alinity i STAT Myoglobin Reagent Kit (LN 04V3720, 04V3730), ARCHITECT STAT Myoglobin Calibrators (LN 2K43-01)
Establishment type
Repack or Relabel Medical Device
Registration
Registration number
3008344661
FEI number
3008344661
Status code
1
Initial importer flag
N
Reg expiry date year
2027
Name
ABBOTT IRELAND
Address line 1
DIAGNOSTICS DIVISION
Address line 2
FINISKLIN BUSINESS PARK
City
SLIGO
Iso country code
IE
Postal code
-
US agent
Name
Sara Qadri
Business name
ABBOTT LABORATORIES
Bus phone area code
224
Bus phone num
6680142
Email address
sara.qadri@abbott.com
Address line 1
675 N Field Dr
Address line 2
Dept C2D8 Bldg CP01 Floor-3
City
Lake Forest
State code
IL
Iso country code
US
Zip code
60045
Owner operator
Firm name
ABBOTT LABORATORIES
Owner operator number
1415939
Contact address
Address 1
100 ABBOTT PARK RD.
Address 2
D-03Q3, AP52-1
City
Abbott Park
State code
IL
Iso country code
US
Postal code
60064
Products
  1. Product code
    DDR
    Created date
    2019-05-31
    Owner operator number
    1415939
    Harmonized identifiers (openFDA)
    Device name
    Myoglobin, Antigen, Antiserum, Control
    Medical specialty description
    Immunology
    Regulation number
    866.5680
    Device class
    2
  2. Product code
    JIS
    Created date
    2019-05-31
    Owner operator number
    1415939
    Harmonized identifiers (openFDA)
    Device name
    Calibrator, Primary
    Medical specialty description
    Clinical Chemistry
    Regulation number
    862.1150
    Device class
    2
Establishments and listings

ACE Calibrator (LN 06U8201), Alinity i Prolactin Calibrators (LN 07P6601) +56

ABBOTT IRELAND · SLIGO, IE

Develop Specifications But Do Not Manufacture At This Facility +1Reg. 3008344661JIT
Proprietary name
ACE Calibrator (LN 06U8201), Alinity i Prolactin Calibrators (LN 07P6601), Alinity i Progesterone Calibrators (LN 08P3601), Alinity i FSH Calibrators (LN 07P4901), Alinity i Total T4 Calibrators (LN 07P9501), Alinity i Free T4 Calibrators (LN 07P7001), Alinity i C-Peptide Calibrators (LN 09P3601), Alinity i 25-OH Vitamin D Calibrators (LN 08P4501), Alinity i Insulin Calibrators (LN 04T7501), Alinity i 2nd Generation Testosterone Calibrators (LN 07P6801), Alinity i Folate Calibrators (LN 08P1402), Alinity i Syphilis TP Calibrator (LN 07P6001), Alinity c Lp(a) Calibrators (LN 01R1401), Alinity i B12 Calibrators (LN 07P6702), Alinity i Active-B12 (Holotranscobalamin) Calibrators (LN 09P2601), Alinity i Estradiol Calibrators (LN 07P5001), Alinity i TSH Calibrators (LN 07P4801), Alinity c Rheumatoid Factor Calibrator Kit (LN 04S0002), Alinity i LH Calibrators (LN 07P9101), Alinity i Total B-hCG Calibrators (LN 07P5101), Alinity i Anti-Tg Calibrators (LN 09P3401), Alinity i T-Uptake Calibrators (LN 08P1201), Alinity i Ferritin Calibrators (LN 07P6501), Alinity i Intact PTH Calibrators (LN 08P3102), ARCHITECT STAT High Sensitivity Troponin-I Calibrators (LN 2R98-01), Alinity c ASO Calibrator (LN 01R0602), Alinity c B2-Microglobulin Calibrator (LN 01R0902), Alinity c Hemoglobin A1c Calibrators (LN 08P4301), Alinity i CA 125 II Calibrators (LN 08P4901), Alinity i DHEA-S Calibrators (LN 09P3701), Alinity i CA 15-3 Calibrators (LN 08P5101), Alinity c Prealbumin Calibrator Kit (LN 04S0101), Alinity i Free T3 Calibrators (LN 07P6901), Alinity c UIBC Calibrator Kit (LN 08P4401), Alinity i Homocysteine Calibrators (LN 09P2801), ARCHITECT Total T3 Calibrators (LN 7K64-02), Alinity i Total T3 Calibrators (LN 07P9401), ARCHITECT Insulin Calibrators (LN 08K4103), Alinity i CA 19-9XR Calibrators (LN 08P3201), Lipase NG OC Calibrator (LN 04Y8501) +18 more
Establishment type
Develop Specifications But Do Not Manufacture At This Facility, Manufacture Medical Device
Registration
Registration number
3008344661
FEI number
3008344661
Status code
1
Initial importer flag
N
Reg expiry date year
2027
Name
ABBOTT IRELAND
Address line 1
DIAGNOSTICS DIVISION
Address line 2
FINISKLIN BUSINESS PARK
City
SLIGO
Iso country code
IE
Postal code
-
US agent
Name
Sara Qadri
Business name
ABBOTT LABORATORIES
Bus phone area code
224
Bus phone num
6680142
Email address
sara.qadri@abbott.com
Address line 1
675 N Field Dr
Address line 2
Dept C2D8 Bldg CP01 Floor-3
City
Lake Forest
State code
IL
Iso country code
US
Zip code
60045
Owner operator
Firm name
ABBOTT LABORATORIES
Owner operator number
1415939
Contact address
Address 1
100 ABBOTT PARK RD.
Address 2
D-03Q3, AP52-1
City
Abbott Park
State code
IL
Iso country code
US
Postal code
60064
Products
  1. Product code
    JIT
    Created date
    2018-05-03
    Owner operator number
    1415939
    Harmonized identifiers (openFDA)
    Device name
    Calibrator, Secondary
    Medical specialty description
    Clinical Chemistry
    Regulation number
    862.1150
    Device class
    2
Establishments and listings

Alinity i STAT CK-MB Reagent Kit (LN 04V3821, 04V3831), ARCHITECt STAT CK-MB Calibrators (LN 2K42-01) +1

ABBOTT IRELAND · SLIGO, IE

Repack or Relabel Medical DeviceReg. 3008344661JISJHX
K number
K041596
Proprietary name
Alinity i STAT CK-MB Reagent Kit (LN 04V3821, 04V3831), ARCHITECt STAT CK-MB Calibrators (LN 2K42-01), ARCHITECT STAT CK-MB Reagent Kit (LN 2K42-25, 2K42-35)
Establishment type
Repack or Relabel Medical Device
Registration
Registration number
3008344661
FEI number
3008344661
Status code
1
Initial importer flag
N
Reg expiry date year
2027
Name
ABBOTT IRELAND
Address line 1
DIAGNOSTICS DIVISION
Address line 2
FINISKLIN BUSINESS PARK
City
SLIGO
Iso country code
IE
Postal code
-
US agent
Name
Sara Qadri
Business name
ABBOTT LABORATORIES
Bus phone area code
224
Bus phone num
6680142
Email address
sara.qadri@abbott.com
Address line 1
675 N Field Dr
Address line 2
Dept C2D8 Bldg CP01 Floor-3
City
Lake Forest
State code
IL
Iso country code
US
Zip code
60045
Owner operator
Firm name
ABBOTT LABORATORIES
Owner operator number
1415939
Contact address
Address 1
100 ABBOTT PARK RD.
Address 2
D-03Q3, AP52-1
City
Abbott Park
State code
IL
Iso country code
US
Postal code
60064
Products
  1. Product code
    JIS
    Created date
    2019-04-08
    Owner operator number
    1415939
    Harmonized identifiers (openFDA)
    Device name
    Calibrator, Primary
    Medical specialty description
    Clinical Chemistry
    Regulation number
    862.1150
    Device class
    2
  2. Product code
    JHX
    Created date
    2019-04-08
    Owner operator number
    1415939
    Harmonized identifiers (openFDA)
    Device name
    Fluorometric Method, Cpk Or Isoenzymes
    Medical specialty description
    Clinical Chemistry
    Regulation number
    862.1215
    Device class
    2

31 records share this identifier (an establishment lists each device separately); the first 10 are shown.

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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.