Identity
- Trade Name
- Antistreptolysin O FDA UDI
- Generic Name
- Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Model / Reference
- 20750948322 FDA UDI
Identifiers
- Catalog Number
- 20750948322 FDA UDI
- Primary DI / UDI-DI
- 04015630913770 FDA UDI
- 510(k) Number
- K954992 FDA UDI
- FDA Product Code
- GTQ FDA UDI
- GMDN Term
- Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.3720 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
No
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
No
FDA UDI
Category: Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, enzyme immunoassay (EIA)
Antistreptolysin O by Roche Diagnostics Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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- Magnesium — Roche Diagnostics Corp.
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- Salicyclate — Roche Diagnostics Corp.
- Salicylate — Roche Diagnostics Corp.
- Serum proteins T Standard — Roche Diagnostics Corp.
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
- Roche Diagnostics Corp.
Sources (1)
- FDA UDI a9feed16-2d6d-4bdc-9e68-7c2fdb0ab27c 35 fields · synced May 30, 2026