FDA Registration
Active
🇺🇸 United States
Alere NT-proBNP for Alinity i Controls (LN 04S7911)
Reg #: 3016438761
·
FEI: 3016438761
·
Expires 2025
Products
1
Proprietary Names
51
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ABBOTT LABORATORIES
- Registration Number
- 3016438761
- FEI Number
- 3016438761
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 1915 Hurd Drive
- City
- Irving
- State
- TX
- ZIP
- 75038
- Country
- US
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
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2017-11-22 |
Proprietary Names
Alere NT-proBNP for Alinity i Controls (LN 04S7911)
FreeStyle Control Solution
Alinity i B12 Controls (LN 07P6712)
Alinity c Ammonia Controls (LN 08P2210)
Alinity i Estradiol Controls (LN 07P5010)
Alinity i Ferritin Controls (LN 07P6510)
Alinity i TSH Controls (LN 07P4810)
Alinity i Free T4 Controls (LN 7P7010)
Alinity i Syphilis TP Controls (LN 07P6010)
Alinity c Hemoglobin A1c Controls (LN 08P4310)
Alinity i DHEA-S Controls (LN 09P3710)
Alinity i Homocysteine Controls (LN 09P2810)
Alinity i FSH Controls (LN 07P4910)
Alinity i Total B-HCG Controls (LN 07P5110)
Alinity i Insulin Controls (LN 04T7510)
Alinity i 2nd Generation Testosterone Controls (LN 07P6810)
Alinity i Prolactin Controls (LN 07P6610)
Alinity i CA 19-9XR Controls (LN 08P3210)
Alinity c Cannabinoids Control 2 Kit (LN 09P5411)
Alinity i Progesterone Controls (LN 08P3610)
Alinity i T-Uptake Controls (LN 08P1210)
Alinity i Folate Controls (LN 08P1412)
Alinity i Intact PTH Controls (LN 08P3111)
Alinity i 25-OH Vitamin D Controls (LN 08P4512)
Alinity i Total T4 Controls (LN 07P9510)
Alinity i C-Peptide Controls (LN 09P3610)
Alinity i Active-B12 (Holotranscobalamin) Controls (LN 09P2610)
Alinity i HE4 Controls (LN 08P5010)
Alinity i Anti-Tg Controls (LN 09P3410)
Lipase NG OC Control 1 (LN 04Y8510)
Alinity c ASO Control I (LN 04S0912)
ARCHITECT STAT High Sensitivity Troponin-I Controls (LN 2R98-10)
Alinity c Lp(a) Control Kit (LN 01R1410)
Alinity i Anti-TPO Controls (LN 09P3510)
Alinity c Cannabinoids Control 1 Kit (LN 09P5410)
Alinity i CA 15-3 Controls (LN 08P5110)
Lipase NG OC Control 2 (LN 04Y8511)
Alinity c ASO Control II (LN 04S0913)
Alinity i CA 125 II Controls (LN 08P4910)
ARCHITECT Insulin Controls (LN 08K4112)
Alinity i Free T3 Controls (LN 07P6910)
MediSense Control Solution
Alinity i STAT High Sensitivity Troponin-I Controls (LN 04Z2110)
GFAP Controls (Alinity i, LN 04W1710)
GFAP Controls (ARCHITECT, LN 4W16-10)
Alinity i BRAHMS PCT Controls (LN 01R1810)
ACE Control (LN 06U8610)
Alinity i CMV IgG Controls (LN 07P4212)
UCH-L1 Controls (Alinity i, LN 04W1910)
UCH-L1 Controls (ARCHITECT, LN 4W18-10)
ACE Control (LN 06U8210)
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility