Identity
- Trade Name
- Group B Strep Assay FDA UDI
- Generic Name
- Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Model / Reference
- GBGBS-10 FDA UDI
Identifiers
- Catalog Number
- GBGBS-10 FDA UDI
- Primary DI / UDI-DI
- B178GBGBS100 FDA UDI
- FDA Product Code
- OOI FDA UDINJR FDA UDI
- GMDN Term
- Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.2570 FDA UDI866.3740 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
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 B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
Group B Strep Assay by Great Basin Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Great Basin Scientific, Inc.
Sources (1)
- FDA UDI 11703581-5ef4-4b63-adf1-78b8b914c66c 35 fields · synced Jun 1, 2026