← Back to catalogue
Group B Streptococcus Detection Kit(Immunochromatography)
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Group B Streptococcus Detection Kit(Immunochromatography) FDA UDI
- Generic Name
- Beta-haemolytic Group B Streptococcus antigen IVD, kit, rapid ICT, clinical FDA UDI
- Model / Reference
- 20 tests/kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974849369137 FDA UDI
- FDA Product Code
- GTY FDA UDI
- GMDN Term
- Beta-haemolytic Group B Streptococcus antigen IVD, kit, rapid ICT, clinical 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
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 antigen IVD, kit, rapid ICT, clinical
Group B Streptococcus Detection Kit(Immunochromatography) by Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Beta-haemolytic Group B Streptococcus antigen IVD, kit, rapid ICT, clinical.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Sources (1)
- FDA UDI 21fae054-b175-4818-867d-93886379a5ca 32 fields · synced May 30, 2026