Identity
- Trade Name
- Triage FDA UDI
- Generic Name
- B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control FDA UDI
- Device Name
- Quidel Triage® BNP Control 1 FDA UDI
- Model / Reference
- 98013XR FDA UDI
- Description
- Quidel Triage® BNP Control 1 FDA UDI
Identifiers
- Catalog Number
- 98013XR FDA UDI
- Primary DI / UDI-DI
- 30014613337010 FDA UDI
- 510(k) Number
- K000230 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control
Triage by Quidel Cardiovascular Inc. — Class I — 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
- Audit MicroControls Linearity FD BNP (Extended) — Aalto Scientific, Ltd.
- Alere NT-proBNP for Alinity Control Kit — Axis-Shield Diagnostics Limited · Class I
- Audit MicroControls Linearity FD BNP RAMP — Aalto Scientific, Ltd.
- Audit MicroControls Linearity FD BNP for Abbott Systems — Aalto Scientific, Ltd.
- ADVIA Centaur NT-PBNPII (PBNPII) — Siemens Healthcare Diagnostics · Class I
- ARCHITECT — Abbott Laboratories, Inc. · Class II
- ADVIA Centaur® ACS:180® Systems BNP 1, 2, 3 QC — Siemens Healthcare Diagnostics · Class II
Cleared under the same submission
K000230 also covers:
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
- Quidel Cardiovascular Inc.
Sources (1)
- FDA UDI 4bd8e37e-cc86-4b09-bdff-e22735a0d89d 36 fields · synced May 30, 2026