Establishments and listings

ADVIA Centaur, Atellica IM

Siemens Healthcare Diagnostics Inc. · Tarrytown, US

Develop Specifications But Do Not Manufacture At This Facility +1Reg. 2432235DLJMKW
K number
K071455
Proprietary name
ADVIA Centaur, Atellica IM
Establishment type
Develop Specifications But Do Not Manufacture At This Facility, Complaint File Establishment per 21 CFR 820.198
Registration
Registration number
2432235
FEI number
2432235
Status code
1
Initial importer flag
Y
Reg expiry date year
2027
Name
Siemens Healthcare Diagnostics Inc.
Address line 1
511 Benedict Ave
City
Tarrytown
State code
NY
Iso country code
US
Zip code
10591
Owner operator
Firm name
SIEMENS HEALTHCARE DIAGNOSTICS INC.
Owner operator number
9096044
Contact address
Address 1
Siemens Healthcare Diagnostics Inc.
Address 2
511 Benedict Avenue
City
Tarrytown
State code
NY
Iso country code
US
Postal code
10591
Products
  1. Product code
    DLJ
    Created date
    2011-06-28
    Owner operator number
    9096044
    Harmonized identifiers (openFDA)
    Device name
    Calibrators, Drug Specific
    Medical specialty description
    Clinical Toxicology
    Regulation number
    862.3200
    Device class
    2
  2. Product code
    MKW
    Created date
    2011-06-28
    Owner operator number
    9096044
    Harmonized identifiers (openFDA)
    Device name
    Cyclosporine
    Medical specialty description
    Clinical Chemistry
    Regulation number
    862.1235
    Device class
    2
    K number
    K071455
Establishments and listings

ADVIA Centaur, ADVIA Centaur Intact PTH IPTH)

Siemens Healthcare Diagnostics Inc. · Tarrytown, US

Complaint File Establishment per 21 CFR 820.198 +1Reg. 2432235CEW
K number
K121981
Proprietary name
ADVIA Centaur, ADVIA Centaur Intact PTH IPTH)
Establishment type
Complaint File Establishment per 21 CFR 820.198, Develop Specifications But Do Not Manufacture At This Facility
Registration
Registration number
2432235
FEI number
2432235
Status code
1
Initial importer flag
Y
Reg expiry date year
2027
Name
Siemens Healthcare Diagnostics Inc.
Address line 1
511 Benedict Ave
City
Tarrytown
State code
NY
Iso country code
US
Zip code
10591
Owner operator
Firm name
SIEMENS HEALTHCARE DIAGNOSTICS INC.
Owner operator number
9096044
Contact address
Address 1
Siemens Healthcare Diagnostics Inc.
Address 2
511 Benedict Avenue
City
Tarrytown
State code
NY
Iso country code
US
Postal code
10591
Products
  1. Product code
    CEW
    Created date
    2013-03-27
    Owner operator number
    9096044
    Harmonized identifiers (openFDA)
    Device name
    Radioimmunoassay, Parathyroid Hormone
    Medical specialty description
    Clinical Chemistry
    Regulation number
    862.1545
    Device class
    2
Establishments and listings

Atellica CH A-LYTE Integrated Multisensor (IMT Na K CI)

Siemens Healthcare Diagnostics Inc. · Tarrytown, US

Complaint File Establishment per 21 CFR 820.198Reg. 2432235CGZJGS
K number
K222438
Proprietary name
Atellica CH A-LYTE Integrated Multisensor (IMT Na K CI)
Establishment type
Complaint File Establishment per 21 CFR 820.198
Registration
Registration number
2432235
FEI number
2432235
Status code
1
Initial importer flag
Y
Reg expiry date year
2027
Name
Siemens Healthcare Diagnostics Inc.
Address line 1
511 Benedict Ave
City
Tarrytown
State code
NY
Iso country code
US
Zip code
10591
Owner operator
Firm name
SIEMENS HEALTHCARE DIAGNOSTICS INC.
Owner operator number
9096044
Contact address
Address 1
Siemens Healthcare Diagnostics Inc.
Address 2
511 Benedict Avenue
City
Tarrytown
State code
NY
Iso country code
US
Postal code
10591
Products
  1. Product code
    CGZ
    Created date
    2023-08-01
    Owner operator number
    9096044
    Harmonized identifiers (openFDA)
    Device name
    Electrode, Ion-Specific, Chloride
    Medical specialty description
    Clinical Chemistry
    Regulation number
    862.1170
    Device class
    2
  2. Product code
    JGS
    Created date
    2023-08-01
    Owner operator number
    9096044
    Harmonized identifiers (openFDA)
    Device name
    Electrode, Ion Specific, Sodium
    Medical specialty description
    Clinical Chemistry
    Regulation number
    862.1665
    Device class
    2
  3. Product code
    CEM
    Created date
    2023-08-01
    Owner operator number
    9096044
    Harmonized identifiers (openFDA)
    Device name
    Electrode, Ion Specific, Potassium
    Medical specialty description
    Clinical Chemistry
    Regulation number
    862.1600
    Device class
    2
Establishments and listings

ADVIA Chemistry A1c_E Pretreatment Buffer Kit, ADVIA Chemistry A1c_E Reagent (2x150 Kit) +3

Siemens Healthcare Diagnostics Inc. · Tarrytown, US

Complaint File Establishment per 21 CFR 820.198 +1Reg. 2432235LCPPDJ
K number
K200256
Proprietary name
ADVIA Chemistry A1c_E Pretreatment Buffer Kit, ADVIA Chemistry A1c_E Reagent (2x150 Kit), ADVIA Chemistry A1c_E Reagent (4x300 Kit), Atellica CH Enzymatic Hemoglobin A1c (A1c_E), Atellica CH A1c_EZ PRE
Establishment type
Complaint File Establishment per 21 CFR 820.198, Develop Specifications But Do Not Manufacture At This Facility
Registration
Registration number
2432235
FEI number
2432235
Status code
1
Initial importer flag
Y
Reg expiry date year
2027
Name
Siemens Healthcare Diagnostics Inc.
Address line 1
511 Benedict Ave
City
Tarrytown
State code
NY
Iso country code
US
Zip code
10591
Owner operator
Firm name
SIEMENS HEALTHCARE DIAGNOSTICS INC.
Owner operator number
9096044
Contact address
Address 1
Siemens Healthcare Diagnostics Inc.
Address 2
511 Benedict Avenue
City
Tarrytown
State code
NY
Iso country code
US
Postal code
10591
Products
  1. Product code
    LCP
    Created date
    2021-07-19
    Owner operator number
    9096044
    Harmonized identifiers (openFDA)
    Device name
    Assay, Glycosylated Hemoglobin
    Medical specialty description
    Hematology
    Regulation number
    864.7470
    Device class
    2
  2. Product code
    PDJ
    Created date
    2021-07-19
    Owner operator number
    9096044
    Harmonized identifiers (openFDA)
    Device name
    Hemoglobin A1c Test System
    Medical specialty description
    Clinical Chemistry
    Regulation number
    862.1373
    Device class
    2
Establishments and listings

ADVIA Centaur, Atellica IM

Siemens Healthcare Diagnostics Inc. · Tarrytown, US

Complaint File Establishment per 21 CFR 820.198 +1Reg. 2432235JIT
K number
K021532
Proprietary name
ADVIA Centaur, Atellica IM
Establishment type
Complaint File Establishment per 21 CFR 820.198, Develop Specifications But Do Not Manufacture At This Facility
Registration
Registration number
2432235
FEI number
2432235
Status code
1
Initial importer flag
Y
Reg expiry date year
2027
Name
Siemens Healthcare Diagnostics Inc.
Address line 1
511 Benedict Ave
City
Tarrytown
State code
NY
Iso country code
US
Zip code
10591
Owner operator
Firm name
SIEMENS HEALTHCARE DIAGNOSTICS INC.
Owner operator number
9096044
Contact address
Address 1
Siemens Healthcare Diagnostics Inc.
Address 2
511 Benedict Avenue
City
Tarrytown
State code
NY
Iso country code
US
Postal code
10591
Products
  1. Product code
    JIT
    Created date
    2007-12-28
    Owner operator number
    9096044
    Harmonized identifiers (openFDA)
    Device name
    Calibrator, Secondary
    Medical specialty description
    Clinical Chemistry
    Regulation number
    862.1150
    Device class
    2
Establishments and listings

ADVIA

Siemens Healthcare Diagnostics Inc. · Tarrytown, US

Develop Specifications But Do Not Manufacture At This Facility +1Reg. 2432235LEH
K number
K881040
Proprietary name
ADVIA
Establishment type
Develop Specifications But Do Not Manufacture At This Facility, Complaint File Establishment per 21 CFR 820.198
Registration
Registration number
2432235
FEI number
2432235
Status code
1
Initial importer flag
Y
Reg expiry date year
2027
Name
Siemens Healthcare Diagnostics Inc.
Address line 1
511 Benedict Ave
City
Tarrytown
State code
NY
Iso country code
US
Zip code
10591
Owner operator
Firm name
SIEMENS HEALTHCARE DIAGNOSTICS INC.
Owner operator number
9096044
Contact address
Address 1
Siemens Healthcare Diagnostics Inc.
Address 2
511 Benedict Avenue
City
Tarrytown
State code
NY
Iso country code
US
Postal code
10591
Products
  1. Product code
    LEH
    Created date
    2011-07-28
    Owner operator number
    9096044
    Harmonized identifiers (openFDA)
    Device name
    Radioimmunoassay, Vancomycin
    Medical specialty description
    Clinical Toxicology
    Regulation number
    862.3950
    Device class
    2
Establishments and listings

ADVIA Chemistry

Siemens Healthcare Diagnostics Inc. · Tarrytown, US

Complaint File Establishment per 21 CFR 820.198 +1Reg. 2432235JIS
K number
K022682
Proprietary name
ADVIA Chemistry
Establishment type
Complaint File Establishment per 21 CFR 820.198, Develop Specifications But Do Not Manufacture At This Facility
Registration
Registration number
2432235
FEI number
2432235
Status code
1
Initial importer flag
Y
Reg expiry date year
2027
Name
Siemens Healthcare Diagnostics Inc.
Address line 1
511 Benedict Ave
City
Tarrytown
State code
NY
Iso country code
US
Zip code
10591
Owner operator
Firm name
SIEMENS HEALTHCARE DIAGNOSTICS INC.
Owner operator number
9096044
Contact address
Address 1
Siemens Healthcare Diagnostics Inc.
Address 2
511 Benedict Avenue
City
Tarrytown
State code
NY
Iso country code
US
Postal code
10591
Products
  1. Product code
    JIS
    Created date
    2012-12-04
    Owner operator number
    9096044
    Harmonized identifiers (openFDA)
    Device name
    Calibrator, Primary
    Medical specialty description
    Clinical Chemistry
    Regulation number
    862.1150
    Device class
    2
Establishments and listings

Atellica CH High Sensitivity C-Reactive Protein 2 (hCRP2)

Siemens Healthcare Diagnostics Inc. · Tarrytown, US

Develop Specifications But Do Not Manufacture At This Facility +1Reg. 2432235NQDJIX
K number
K233242
Proprietary name
Atellica CH High Sensitivity C-Reactive Protein 2 (hCRP2)
Establishment type
Develop Specifications But Do Not Manufacture At This Facility, Complaint File Establishment per 21 CFR 820.198
Registration
Registration number
2432235
FEI number
2432235
Status code
1
Initial importer flag
Y
Reg expiry date year
2027
Name
Siemens Healthcare Diagnostics Inc.
Address line 1
511 Benedict Ave
City
Tarrytown
State code
NY
Iso country code
US
Zip code
10591
Owner operator
Firm name
SIEMENS HEALTHCARE DIAGNOSTICS INC.
Owner operator number
9096044
Contact address
Address 1
Siemens Healthcare Diagnostics Inc.
Address 2
511 Benedict Avenue
City
Tarrytown
State code
NY
Iso country code
US
Postal code
10591
Products
  1. Product code
    NQD
    Created date
    2024-01-25
    Owner operator number
    9096044
    Harmonized identifiers (openFDA)
    Device name
    Cardiac C-Reactive Protein, Antigen, Antiserum, And Control
    Medical specialty description
    Immunology
    Regulation number
    866.5270
    Device class
    2
  2. Product code
    JIX
    Created date
    2024-01-25
    Owner operator number
    9096044
    Harmonized identifiers (openFDA)
    Device name
    Calibrator, Multi-Analyte Mixture
    Medical specialty description
    Clinical Chemistry
    Regulation number
    862.1150
    Device class
    2
Establishments and listings

ADVIA Centaur, Atellica IM Toxoplasma IgG Quality Control (Toxo G QC) +1

Siemens Healthcare Diagnostics Inc. · Tarrytown, US

Complaint File Establishment per 21 CFR 820.198 +1Reg. 2432235LGD
K number
K012183
Proprietary name
ADVIA Centaur, Atellica IM Toxoplasma IgG Quality Control (Toxo G QC), Atellica IM Toxoplasma IgG (Toxo G)
Establishment type
Complaint File Establishment per 21 CFR 820.198, Develop Specifications But Do Not Manufacture At This Facility
Registration
Registration number
2432235
FEI number
2432235
Status code
1
Initial importer flag
Y
Reg expiry date year
2027
Name
Siemens Healthcare Diagnostics Inc.
Address line 1
511 Benedict Ave
City
Tarrytown
State code
NY
Iso country code
US
Zip code
10591
Owner operator
Firm name
SIEMENS HEALTHCARE DIAGNOSTICS INC.
Owner operator number
9096044
Contact address
Address 1
Siemens Healthcare Diagnostics Inc.
Address 2
511 Benedict Avenue
City
Tarrytown
State code
NY
Iso country code
US
Postal code
10591
Products
  1. Product code
    LGD
    Created date
    2007-12-28
    Owner operator number
    9096044
    Harmonized identifiers (openFDA)
    Device name
    Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
    Medical specialty description
    Microbiology
    Regulation number
    866.3780
    Device class
    2
Establishments and listings

ADVIA Chemistry, Atellica CH Complement C3 (C3)

Siemens Healthcare Diagnostics Inc. · Tarrytown, US

Complaint File Establishment per 21 CFR 820.198 +1Reg. 2432235CZW
K number
K000469
Proprietary name
ADVIA Chemistry, Atellica CH Complement C3 (C3)
Establishment type
Complaint File Establishment per 21 CFR 820.198, Develop Specifications But Do Not Manufacture At This Facility
Registration
Registration number
2432235
FEI number
2432235
Status code
1
Initial importer flag
Y
Reg expiry date year
2027
Name
Siemens Healthcare Diagnostics Inc.
Address line 1
511 Benedict Ave
City
Tarrytown
State code
NY
Iso country code
US
Zip code
10591
Owner operator
Firm name
SIEMENS HEALTHCARE DIAGNOSTICS INC.
Owner operator number
9096044
Contact address
Address 1
Siemens Healthcare Diagnostics Inc.
Address 2
511 Benedict Avenue
City
Tarrytown
State code
NY
Iso country code
US
Postal code
10591
Products
  1. Product code
    CZW
    Created date
    2008-01-07
    Owner operator number
    9096044
    Harmonized identifiers (openFDA)
    Device name
    Complement C3, Antigen, Antiserum, Control
    Medical specialty description
    Immunology
    Regulation number
    866.5240
    Device class
    2

445 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.