Establishments and listings

EUROPicture, EUROStar III Plus +1

EUROIMMUN US INC. · Mountain Lakes, US

Complaint File Establishment per 21 CFR 820.198Reg. 3007118747KEI
Proprietary name
EUROPicture, EUROStar III Plus, EUROStar IV Plus
Establishment type
Complaint File Establishment per 21 CFR 820.198
Registration
Registration number
3007118747
FEI number
3007118747
Status code
1
Initial importer flag
Y
Reg expiry date year
2026
Name
EUROIMMUN US INC.
Address line 1
1 Bloomfield Ave
City
Mountain Lakes
State code
NJ
Iso country code
US
Zip code
07046
Owner operator
Firm name
EUROIMMUN US Inc.
Owner operator number
10025673
Contact address
Address 1
1 Bloomfield Ave.
City
Mountain Lakes
State code
NJ
Iso country code
US
Postal code
07046
Products
  1. Product code
    KEI
    Created date
    2009-10-27
    Owner operator number
    10025673
    Harmonized identifiers (openFDA)
    Device name
    Condensers, Microscope
    Medical specialty description
    Pathology
    Regulation number
    864.3600
    Device class
    1
Establishments and listings

IDS-iSYS Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Calibration Verifiers, IDS-iSYS Human Growth Hormone (hGH) Calibration Verifiers +1

EUROIMMUN US INC. · Mountain Lakes, US

Complaint File Establishment per 21 CFR 820.198Reg. 3007118747JJX
K number
K111938
Proprietary name
IDS-iSYS Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Calibration Verifiers, IDS-iSYS Human Growth Hormone (hGH) Calibration Verifiers, IDS-iSYS Insulin-like Growth Factor Binding Protein 3 (IGFBP-3) Control Set
Establishment type
Complaint File Establishment per 21 CFR 820.198
Registration
Registration number
3007118747
FEI number
3007118747
Status code
1
Initial importer flag
Y
Reg expiry date year
2026
Name
EUROIMMUN US INC.
Address line 1
1 Bloomfield Ave
City
Mountain Lakes
State code
NJ
Iso country code
US
Zip code
07046
Owner operator
Firm name
EUROIMMUN US Inc.
Owner operator number
10025673
Contact address
Address 1
1 Bloomfield Ave.
City
Mountain Lakes
State code
NJ
Iso country code
US
Postal code
07046
Products
  1. Product code
    JJX
    Created date
    2023-08-04
    Owner operator number
    10025673
    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

Anti-PLA2R IFA

EUROIMMUN US INC. · Mountain Lakes, US

Complaint File Establishment per 21 CFR 820.198Reg. 3007118747PGV
K number
DEN140002
Proprietary name
Anti-PLA2R IFA
Establishment type
Complaint File Establishment per 21 CFR 820.198
Registration
Registration number
3007118747
FEI number
3007118747
Status code
1
Initial importer flag
Y
Reg expiry date year
2026
Name
EUROIMMUN US INC.
Address line 1
1 Bloomfield Ave
City
Mountain Lakes
State code
NJ
Iso country code
US
Zip code
07046
Owner operator
Firm name
EUROIMMUN US Inc.
Owner operator number
10025673
Contact address
Address 1
1 Bloomfield Ave.
City
Mountain Lakes
State code
NJ
Iso country code
US
Postal code
07046
Products
  1. Product code
    PGV
    Created date
    2014-06-03
    Owner operator number
    10025673
    Harmonized identifiers (openFDA)
    Device name
    Anti-Phospholipase A2 Receptor
    Medical specialty description
    Microbiology
    Regulation number
    866.5780
    Device class
    2
Establishments and listings

Anti-SLA/LP ELISA (IgG)

EUROIMMUN US INC. · Mountain Lakes, US

Complaint File Establishment per 21 CFR 820.198Reg. 3007118747NIY
K number
K112221
Proprietary name
Anti-SLA/LP ELISA (IgG)
Establishment type
Complaint File Establishment per 21 CFR 820.198
Registration
Registration number
3007118747
FEI number
3007118747
Status code
1
Initial importer flag
Y
Reg expiry date year
2026
Name
EUROIMMUN US INC.
Address line 1
1 Bloomfield Ave
City
Mountain Lakes
State code
NJ
Iso country code
US
Zip code
07046
Owner operator
Firm name
EUROIMMUN US Inc.
Owner operator number
10025673
Contact address
Address 1
1 Bloomfield Ave.
City
Mountain Lakes
State code
NJ
Iso country code
US
Postal code
07046
Products
  1. Product code
    NIY
    Created date
    2012-09-18
    Owner operator number
    10025673
    Harmonized identifiers (openFDA)
    Device name
    Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis
    Medical specialty description
    Immunology
    Regulation number
    866.5660
    Device class
    2
Establishments and listings

Anti-RSV ELISA (IgG)

EUROIMMUN US INC. · Mountain Lakes, US

Complaint File Establishment per 21 CFR 820.198Reg. 3007118747MCE
Proprietary name
Anti-RSV ELISA (IgG)
Establishment type
Complaint File Establishment per 21 CFR 820.198
Registration
Registration number
3007118747
FEI number
3007118747
Status code
1
Initial importer flag
Y
Reg expiry date year
2026
Name
EUROIMMUN US INC.
Address line 1
1 Bloomfield Ave
City
Mountain Lakes
State code
NJ
Iso country code
US
Zip code
07046
Owner operator
Firm name
EUROIMMUN US Inc.
Owner operator number
10025673
Contact address
Address 1
1 Bloomfield Ave.
City
Mountain Lakes
State code
NJ
Iso country code
US
Postal code
07046
Products
  1. Product code
    MCE
    Created date
    2008-10-20
    Owner operator number
    10025673
    Harmonized identifiers (openFDA)
    Device name
    Respiratory Syncytial Virus - Elisa
    Medical specialty description
    Microbiology
    Regulation number
    866.3480
    Device class
    1
Establishments and listings

Anti-Gliadin (GAF-3X) ELISA (IgA)

EUROIMMUN US INC. · Mountain Lakes, US

Complaint File Establishment per 21 CFR 820.198Reg. 3007118747MST
K number
K083052
Proprietary name
Anti-Gliadin (GAF-3X) ELISA (IgA)
Establishment type
Complaint File Establishment per 21 CFR 820.198
Registration
Registration number
3007118747
FEI number
3007118747
Status code
1
Initial importer flag
Y
Reg expiry date year
2026
Name
EUROIMMUN US INC.
Address line 1
1 Bloomfield Ave
City
Mountain Lakes
State code
NJ
Iso country code
US
Zip code
07046
Owner operator
Firm name
EUROIMMUN US Inc.
Owner operator number
10025673
Contact address
Address 1
1 Bloomfield Ave.
City
Mountain Lakes
State code
NJ
Iso country code
US
Postal code
07046
Products
  1. Product code
    MST
    Created date
    2009-07-31
    Owner operator number
    10025673
    Harmonized identifiers (openFDA)
    Device name
    Antibodies, Gliadin
    Medical specialty description
    Immunology
    Regulation number
    866.5750
    Device class
    2
Establishments and listings

EUROLINE-WB Anti-Echinococcus (IgG), Anti-Echinococcus ELISA (IgG) +1

EUROIMMUN US INC. · Mountain Lakes, US

Complaint File Establishment per 21 CFR 820.198Reg. 3007118747GPE
Proprietary name
EUROLINE-WB Anti-Echinococcus (IgG), Anti-Echinococcus ELISA (IgG), Anti-Echinococcus EUROLINE WB (IgG)
Establishment type
Complaint File Establishment per 21 CFR 820.198
Registration
Registration number
3007118747
FEI number
3007118747
Status code
1
Initial importer flag
Y
Reg expiry date year
2026
Name
EUROIMMUN US INC.
Address line 1
1 Bloomfield Ave
City
Mountain Lakes
State code
NJ
Iso country code
US
Zip code
07046
Owner operator
Firm name
EUROIMMUN US Inc.
Owner operator number
10025673
Contact address
Address 1
1 Bloomfield Ave.
City
Mountain Lakes
State code
NJ
Iso country code
US
Postal code
07046
Products
  1. Product code
    GPE
    Created date
    2008-10-16
    Owner operator number
    10025673
    Harmonized identifiers (openFDA)
    Device name
    Antisera, Positive Control, Echinococcus Spp.
    Medical specialty description
    Microbiology
    Regulation number
    866.3200
    Device class
    1
Establishments and listings

IFA 40: HEp-20-10

EUROIMMUN US INC. · Mountain Lakes, US

Manufacture Medical Device for Another Party (Contract Manufacturer)Reg. 3007118747DHN
Proprietary name
IFA 40: HEp-20-10
Establishment type
Manufacture Medical Device for Another Party (Contract Manufacturer)
Registration
Registration number
3007118747
FEI number
3007118747
Status code
1
Initial importer flag
Y
Reg expiry date year
2026
Name
EUROIMMUN US INC.
Address line 1
1 Bloomfield Ave
City
Mountain Lakes
State code
NJ
Iso country code
US
Zip code
07046
Owner operator
Firm name
EUROIMMUN US Inc.
Owner operator number
10025673
Contact address
Address 1
1 Bloomfield Ave.
City
Mountain Lakes
State code
NJ
Iso country code
US
Postal code
07046
Products
  1. Product code
    DHN
    Created date
    2014-03-25
    Owner operator number
    10025673
    Harmonized identifiers (openFDA)
    Device name
    Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
    Medical specialty description
    Immunology
    Regulation number
    866.5100
    Device class
    2
Establishments and listings

IDS-iSYS CTX-I (Crosslaps) Control Set

EUROIMMUN US INC. · Mountain Lakes, US

Complaint File Establishment per 21 CFR 820.198Reg. 3007118747JJX
K number
K111650
Proprietary name
IDS-iSYS CTX-I (Crosslaps) Control Set
Establishment type
Complaint File Establishment per 21 CFR 820.198
Registration
Registration number
3007118747
FEI number
3007118747
Status code
1
Initial importer flag
Y
Reg expiry date year
2026
Name
EUROIMMUN US INC.
Address line 1
1 Bloomfield Ave
City
Mountain Lakes
State code
NJ
Iso country code
US
Zip code
07046
Owner operator
Firm name
EUROIMMUN US Inc.
Owner operator number
10025673
Contact address
Address 1
1 Bloomfield Ave.
City
Mountain Lakes
State code
NJ
Iso country code
US
Postal code
07046
Products
  1. Product code
    JJX
    Created date
    2023-08-04
    Owner operator number
    10025673
    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

Free Estriol ELISA

EUROIMMUN US INC. · Mountain Lakes, US

Complaint File Establishment per 21 CFR 820.198Reg. 3007118747CGI
Proprietary name
Free Estriol ELISA
Establishment type
Complaint File Establishment per 21 CFR 820.198
Registration
Registration number
3007118747
FEI number
3007118747
Status code
1
Initial importer flag
Y
Reg expiry date year
2026
Name
EUROIMMUN US INC.
Address line 1
1 Bloomfield Ave
City
Mountain Lakes
State code
NJ
Iso country code
US
Zip code
07046
Owner operator
Firm name
EUROIMMUN US Inc.
Owner operator number
10025673
Contact address
Address 1
1 Bloomfield Ave.
City
Mountain Lakes
State code
NJ
Iso country code
US
Postal code
07046
Products
  1. Product code
    CGI
    Created date
    2021-10-25
    Owner operator number
    10025673
    Harmonized identifiers (openFDA)
    Device name
    Radioimmunoassay, Estriol
    Medical specialty description
    Clinical Chemistry
    Regulation number
    862.1265
    Device class
    1

106 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.