Identity
- Trade Name
- Alere NT-proBNP for Alinity Control Kit FDA UDI
- Generic Name
- B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control FDA UDI
- Device Name
- The Alere NT-proBNP for Alinity i Controls are for the estimation of test precision and the detection of systematic analytical deviations of the Alinity i analyzer when used for the quantitative determination of N-terminal pro B-type natriuretic peptide (NT-proBNP) in human serum and plasma. For additional information, refer to the Alere NT-proBNP for Alinity i reagent package insert and the Alinity ci-series Operations Manual. FDA UDI
- Model / Reference
- 04S7911 FDA UDI
- Description
- The Alere NT-proBNP for Alinity i Controls are for the estimation of test precision and the detection of systematic analytical deviations of the Alinity i analyzer when used for the quantitative determination of N-terminal pro B-type natriuretic peptide (NT-proBNP) in human serum and plasma. For additional information, refer to the Alere NT-proBNP for Alinity i reagent package insert and the Alinity ci-series Operations Manual. FDA UDI
Identifiers
- Catalog Number
- 04S7911 FDA UDI
- Primary DI / UDI-DI
- 05055845400527 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control
Alere NT-proBNP for Alinity Control Kit by Axis-Shield Diagnostics Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Axis-Shield Diagnostics Limited
Sources (1)
- FDA UDI cf12249b-4bd7-466d-b46f-478bead907a7 35 fields · synced May 30, 2026