FDA Registration
Active
🇩🇪 Germany
Alere NT-proBNP for Alinity i Calibrators (LN 04S7902)
Reg #: 3002809144
·
FEI: 3002809144
·
Expires 2025
Products
1
Proprietary Names
57
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- ABBOTT GmbH
- Registration Number
- 3002809144
- FEI Number
- 3002809144
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Max-Planck-Ring 2
- City
- Wiesbaden Hesse
- Country
- DE
Owner / Operator
- Firm Name
- ABBOTT LABORATORIES
- Operator Number
- 1415939
- Address
- 100 ABBOTT PARK RD., D-03Q3, AP52-1
- City
- Abbott Park
- State
- IL
- Postal Code
- 60064
- Country
- US
US Agent
- Business Name
- ABBOTT LABORATORIES
- Contact Name
- Sara Qadri
- Address
- 675 N Field Dr, Dept C2D8 Bldg CP01 Floor-3
- City
- Lake Forest
- State
- IL
- ZIP
- 60045
- Country
- US
- [email protected]
- Phone
- 224 6680142
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Calibrator, Secondary | JIT | Class 2 | Clinical Chemistry | No | 2018-05-03 |
Proprietary Names
Alere NT-proBNP for Alinity i Calibrators (LN 04S7902)
ACE Calibrator (LN 06U8601)
Alinity i 25-OH Vitamin D Calibrators (LN 08P4501)
Alinity i Estradiol Calibrators (LN 07P5001)
Alinity i Syphilis TP Calibrator (LN 07P6001)
Alinity i 2nd Generation Testosterone Calibrators (LN 07P6801)
Alinity i Total T4 Calibrators (LN 07P9501)
Alinity i Progesterone Calibrators (LN 08P3601)
Alinity i FSH Calibrators (LN 07P4901)
Alinity i B12 Calibrators (LN 07P6702)
Alinity i Insulin Calibrators (LN 04T7501)
Alinity i Folate Calibrators (LN 08P1402)
Alinity i Total B-hCG Calibrators (LN 07P5101)
Alinity i C-Peptide Calibrators (LN 09P3601)
Alinity i LH Calibrators (LN 07P9101)
Alinity i Prolactin Calibrators (LN 07P6601)
Alinity c Rheumatoid Factor Calibrator Kit (LN 04S0002)
Alinity c ASO Calibrator (LN 01R0602)
Alinity i TSH Calibrators (LN 07P4801)
Alinity i Free T4 Calibrators (LN 07P7001)
Lipase NG OC Calibrator (LN 04Y8501)
Alinity i Active-B12 (Holotranscobalamin) Calibrators (LN 09P2601)
Alinity i Ferritin Calibrators (LN 07P6501)
Alinity c Prealbumin Calibrator Kit (LN 04S0101)
Alinity i Intact PTH Calibrators (LN 08P3102)
ARCHITECT STAT High Sensitivity Troponin-I Calibrators (LN 2R98-01)
Alinity c UIBC Calibrator Kit (LN 08P4401)
Alinity i Tacrolimus Calibrators (LN 09P4201)
Alinity c B2-Microglobulin Calibrator (LN 01R0902)
Alinity i Homocysteine Calibrators (LN 09P2801)
Prealbumin Calibrator (LN 6E57-03)
Alinity c Hemoglobin A1c Calibrators (LN 08P4301)
Alinity i DHEA-S Calibrators (LN 09P3701)
Alinity c Lp(a) Calibrators (LN 01R1401)
Alinity i Free T3 Calibrators (LN 07P6901)
Alinity i Anti-TPO Calibrators (LN 09P3501)
Alinity i HE4 Calibrators (LN 08P5001)
Alinity i Cortisol Calibrators (LN 08P3301)
Alinity i Anti-Tg Calibrators (LN 09P3401)
Alinity i T-Uptake Calibrators (LN 08P1201)
Alinity i CA 15-3 Calibrators (LN 08P5101)
Alinity i CA 125 II Calibrators (LN 08P4901)
Alinity i CA 19-9XR Calibrators (LN 08P3201)
Alinity i Total T3 Calibrators (LN 07P9401)
Alinity i Sirolimus Calibrators (LN 09P4101)
ARCHITECT Total T3 Calibrators (LN 7K64-02)
ARCHITECT Insulin Calibrators (LN 08K4103)
Acetaminophen Calibrator (Alinity c, LN 07P5401)
Alinity i STAT High Sensitivity Troponin-I Calibrators (LN 04Z2101)
GFAP Calibrators (Alinity i, LN 04W1701)
UCH-L1 Calibrators (ARCHITECT, LN 4W18-01)
Acetaminophen Calibrator (LN 03R7401)
Alinity i CMV IgG Calibrators (LN 07P4202)
UCH-L1 Calibrators (Alinity i, LN 04W1901)
ACE Calibrator (LN 06U8201)
Alinity i BRAHMS PCT Calibrators (LN 01R1801)
GFAP Calibrators (ARCHITECT, LN 4W16-01)
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device