Establishments and listings

IDS-iSYS XPrep

EUROIMMUN US INC. · Mountain Lakes, US

Complaint File Establishment per 21 CFR 820.198Reg. 3007118747JRQ
Proprietary name
IDS-iSYS XPrep
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
    JRQ
    Created date
    2023-08-04
    Owner operator number
    10025673
    Harmonized identifiers (openFDA)
    Device name
    Shaker/Stirrer
    Medical specialty description
    Clinical Chemistry
    Regulation number
    862.2050
    Device class
    1
Establishments and listings

IDS-iSYS CTX-I (Crosslaps) Calibration Verifiers

EUROIMMUN US INC. · Mountain Lakes, US

Complaint File Establishment per 21 CFR 820.198Reg. 3007118747JJX
K number
K143324
Proprietary name
IDS-iSYS CTX-I (Crosslaps) Calibration Verifiers
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
    2023-08-11
    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-West Nile Virus ELISA (IgM)

EUROIMMUN US INC. · Mountain Lakes, US

Complaint File Establishment per 21 CFR 820.198Reg. 3007118747NOP
K number
K153308
Proprietary name
Anti-West Nile Virus ELISA (IgM)
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
    NOP
    Created date
    2016-08-30
    Owner operator number
    10025673
    Harmonized identifiers (openFDA)
    Device name
    Elisa, Antibody, West Nile Virus
    Medical specialty description
    Microbiology
    Regulation number
    866.3940
    Device class
    2
Establishments and listings

Anti-Desmoglein 3 ELISA (IgG), Anti-Desmoglein 1 ELISA (IgG)

EUROIMMUN US INC. · Mountain Lakes, US

Complaint File Establishment per 21 CFR 820.198Reg. 3007118747NBO
K number
K091969
Proprietary name
Anti-Desmoglein 3 ELISA (IgG), Anti-Desmoglein 1 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
    NBO
    Created date
    2010-11-19
    Owner operator number
    10025673
    Harmonized identifiers (openFDA)
    Device name
    Autoantibodies, Skin (Desmoglein 1 And Desmoglein 3)
    Medical specialty description
    Immunology
    Regulation number
    866.5660
    Device class
    2
    K number
    K091969
Establishments and listings

N-MID® Osteocalcin ELISA

EUROIMMUN US INC. · Mountain Lakes, US

Complaint File Establishment per 21 CFR 820.198Reg. 3007118747NEO
K number
K003609
Proprietary name
N-MID® Osteocalcin 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
    NEO
    Created date
    2023-08-04
    Owner operator number
    10025673
    Harmonized identifiers (openFDA)
    Device name
    System, Test, Osteocalcin
    Medical specialty description
    Clinical Chemistry
    Regulation number
    862.1050
    Device class
    2
    K number
    K003609
Establishments and listings

IDS ACTH II

EUROIMMUN US INC. · Mountain Lakes, US

Complaint File Establishment per 21 CFR 820.198Reg. 3007118747CKG
K number
K223867
Proprietary name
IDS ACTH II
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
    CKG
    Created date
    2023-11-10
    Owner operator number
    10025673
    Harmonized identifiers (openFDA)
    Device name
    Radioimmunoassay, Acth
    Medical specialty description
    Clinical Chemistry
    Regulation number
    862.1025
    Device class
    2
Establishments and listings

EUROLINE Bordetella pertussis (IgG)

EUROIMMUN US INC. · Mountain Lakes, US

Complaint File Establishment per 21 CFR 820.198Reg. 3007118747GOX
Proprietary name
EUROLINE Bordetella pertussis (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
    GOX
    Created date
    2009-10-27
    Owner operator number
    10025673
    Harmonized identifiers (openFDA)
    Device name
    Antigen, B. Pertussis
    Medical specialty description
    Microbiology
    Regulation number
    866.3065
    Device class
    1
Establishments and listings

Anti-Strongyloides ELISA (IgG)

EUROIMMUN US INC. · Mountain Lakes, US

Complaint File Establishment per 21 CFR 820.198Reg. 3007118747MDT
Proprietary name
Anti-Strongyloides 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
    MDT
    Created date
    2017-11-07
    Owner operator number
    10025673
    Harmonized identifiers (openFDA)
    Device name
    Elisa, Trichinella Spiralis
    Medical specialty description
    Microbiology
    Regulation number
    866.3850
    Device class
    1
Establishments and listings

IDS SHBG Control Set, IDS-iSYS Ostase® BAP Calibration Verifiers +12

EUROIMMUN US INC. · Mountain Lakes, US

Complaint File Establishment per 21 CFR 820.198Reg. 3007118747JJX
Proprietary name
IDS SHBG Control Set, IDS-iSYS Ostase® BAP Calibration Verifiers, IDS Cortisol Calibrator Set, IDS SHBG Calibration Verifiers, IDS Androstenedione Calibrator Set, IDS Beta CrossLaps® (CTX-I) Calibrator Set, IDS ACTH II Calibrator Set, IDS Androstenedione Control Set, IDS Cortisol Control Set, IDS-iSYS Ostase® BAP Control Set, IDS Prolactin Calibrator Set, IDS Beta CrossLaps® (CTX-I) Control Set, IDS ACTH II Control Set, IDS-iSYS Free Testosterone 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
    2023-11-10
    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 Testosterone ELISA

EUROIMMUN US INC. · Mountain Lakes, US

Complaint File Establishment per 21 CFR 820.198Reg. 3007118747CDZ
K number
K030730
Proprietary name
Free Testosterone 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
    CDZ
    Created date
    2021-01-12
    Owner operator number
    10025673
    Harmonized identifiers (openFDA)
    Device name
    Radioimmunoassay, Testosterones And Dihydrotestosterone
    Medical specialty description
    Clinical Chemistry
    Regulation number
    862.1680
    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.