Identity
- Trade Name
- NG-Test CARBA 5 FDA UDI
- Generic Name
- Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, kit FDA UDI
- Device Name
- Rapid test for the detection of carbapenemases KPC, OXA, VIM, IMP and NDM in a bacterial colony from culture. FDA UDI
- Model / Reference
- Kit of 20 tests for US FDA UDI
- Description
- Rapid test for the detection of carbapenemases KPC, OXA, VIM, IMP and NDM in a bacterial colony from culture. FDA UDI
Identifiers
- Catalog Number
- NGB-CAR-S23-018 FDA UDI
- Primary DI / UDI-DI
- 03701077400133 FDA UDI
- 510(k) Number
- K191889 FDA UDI
- FDA Product Code
- PTJ FDA UDI
- GMDN Term
- Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.1640 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
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
Category: Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, kit
NG-Test CARBA 5 by Ng Biotech — Class II — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Ng Biotech
Sources (2)
- FDA UDI 9c5d2de8-2e97-4ef9-a7b4-9c139aab5014 37 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 2, 2026