Identity
- Trade Name
- Wampole ColorCard® Streptozyme® FDA UDI
- Generic Name
- Beta-haemolytic Group A Streptococcus total antibody IVD, kit, agglutination FDA UDI
- Model / Reference
- 46050 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10859035006221 FDA UDI
- FDA Product Code
- GTY FDA UDI
- GMDN Term
- Beta-haemolytic Group A Streptococcus total antibody IVD, kit, agglutination FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.3740 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
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
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: Beta-haemolytic Group A Streptococcus total antibody IVD, kit, agglutination
Wampole ColorCard® Streptozyme® by Alere North America, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Beta-haemolytic Group A Streptococcus total antibody IVD, kit, agglutination.
- Wampole ColorCard® ASO — ALERE NORTH AMERICA, LLC · 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 | Class I | Pending data |
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Manufacturer
- Manufacturer
- Alere North America, Llc
Sources (1)
- FDA UDI f8aff050-c047-49dc-a796-02ca1f24114b 34 fields · synced May 30, 2026