Identity
- Trade Name
- Alere Triage® FDA UDI
- Generic Name
- Multiple cardiac marker IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- Alere Triage® Cardiac Panel FDA UDI
- Model / Reference
- 97000HS FDA UDI
- Description
- Alere Triage® Cardiac Panel FDA UDI
Identifiers
- Catalog Number
- 97000HS FDA UDI
- Primary DI / UDI-DI
- 00893038002197 FDA UDI
- FDA Product Code
- DDR FDA UDIMMI FDA UDIJHX FDA UDI
- GMDN Term
- Multiple cardiac marker IVD, kit, fluorescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5680 FDA UDI862.1215 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Alere Triage® by Alere San Diego, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 II | Pending data |
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Manufacturer
- Manufacturer
- Alere San Diego, Inc.
Sources (1)
- FDA UDI bd5271cd-0f15-4e0d-8dd7-b2d4cf6c763c 37 fields · synced Jun 9, 2026