Identity
- Trade Name
- ASO Titer Control FDA UDI
- Generic Name
- Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, control FDA UDI
- Device Name
- 2 x 0.5 ml titrated control FDA UDI
- Model / Reference
- 300021060 FDA UDI
- Description
- 2 x 0.5 ml titrated control FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08426950590453 FDA UDI
- FDA Product Code
- GTQ FDA UDI
- GMDN Term
- Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.3720 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
No
FDA UDI
ASO Titer Control by Biokit, S.a. — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Biokit, S.a.
Sources (1)
- FDA UDI 0f6c68f7-35ce-4eb1-8983-9ad6ac04d27b 36 fields · synced May 31, 2026