Identity
- Trade Name
- Triage® FDA UDI
- Generic Name
- Multiple faecal parasite antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Triage® Micro Parasite Panel FDA UDI
- Model / Reference
- 96100 FDA UDI
- Description
- Triage® Micro Parasite Panel FDA UDI
Identifiers
- Catalog Number
- 96100 FDA UDI
- Primary DI / UDI-DI
- 00893038002180 FDA UDI
- FDA Product Code
- GMO FDA UDIMHJ FDA UDIMHI FDA UDI
- GMDN Term
- Multiple faecal parasite antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3220 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
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Alere San Diego, Inc.
Sources (1)
- FDA UDI a50c35c1-046c-40b7-998c-d42d75f83a3d 36 fields · synced Jun 9, 2026