← Back to catalogue
Audit MicroControls Linearity FD BNP (Extended)
FDA UDIIdentity
- Trade Name
- Audit MicroControls Linearity FD BNP (Extended) FDA UDI
- Generic Name
- B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control FDA UDI
- Model / Reference
- K737M-5 FDA UDI
Identifiers
- Primary DI / UDI-DI
- B085K737M50 FDA UDI
- GMDN Term
- B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
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
Audit MicroControls Linearity FD BNP (Extended) by Aalto Scientific, Ltd. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control.
- ATELLICA IM NT-PBNPII (PBNPII) — Siemens Healthcare Diagnostics · Class I
- Alere NT-proBNP for Alinity Control Kit — Axis-Shield Diagnostics Limited · Class I
- Triage — Quidel Cardiovascular Inc. · Class I
- ADVIA Centaur NT-PBNPII (PBNPII) — Siemens Healthcare Diagnostics · Class I
- Triage — Quidel Cardiovascular Inc. · Class I
- ARCHITECT — Abbott Laboratories, Inc. · Class II
- ADVIA Centaur® ACS:180® Systems BNP 1, 2, 3 QC — Siemens Healthcare Diagnostics · Class II
- Triage — Quidel Cardiovascular Inc. · Class I
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 | N/A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Aalto Scientific, Ltd.
Sources (1)
- FDA UDI f1296855-f3e4-4d95-bdea-46c841f6d7b1 32 fields · synced May 30, 2026