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Freeze-dried Group B Streptococcus Nucleic Acid Detection Kit(Fluorescence PCR)
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Freeze-dried Group B Streptococcus Nucleic Acid Detection Kit(Fluorescence PCR) FDA UDI
- Generic Name
- Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Model / Reference
- 50 tests/kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974849369267 FDA UDI
- FDA Product Code
- NJR FDA UDI
- GMDN Term
- Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
Freeze-dried Group B Streptococcus Nucleic Acid Detection Kit(Fluorescence PCR) by Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. — Class I — FDA UDI — listed…
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Sources (1)
- FDA UDI 35d45677-356d-48f0-9468-ec95d130995f 32 fields · synced May 30, 2026