NG-TEST CTX-M Multi
FDA UDIEUDAMEDClass II (US FDA UDI)
by Ng Biotech
Identity
- Trade Name
- NG-TEST CTX-M Multi EUDAMEDFDA UDI
- Generic Name
- Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, kit FDA UDI
- Device Name
- NG-TEST CTX-M Multi EUDAMEDRapid test for the detection of CTX-M enzymes (groups 1, 2, 8, 9, and 25) in a bacterial colony from culture. FDA UDI
- Model / Reference
- NGB-CTM-S23-016 EUDAMEDKit of 20 tests for US FDA UDI
- Description
- Rapid test for the detection of CTX-M enzymes (groups 1, 2, 8, 9, and 25) in a bacterial colony from culture. FDA UDI
Identifiers
- Catalog Number
- NGB-CTM-S23-018 FDA UDI
- Primary DI / UDI-DI
- 03701077401536 EUDAMED03701077402274 FDA UDI
- Basic UDI-DI
- B-03701077401536 EUDAMED
- 510(k) Number
- K243499 FDA UDI
- FDA Product Code
- PTJ FDA UDI
- EMDN Code
- W010407 MICROBIOLOGY RT & POC EUDAMED
- GMDN Term
- Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, kit FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 866.1640 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
Yes
Microbial Substances
No
Reagent
No
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, kit
NG-TEST CTX-M Multi 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
IVDD
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 d1ec8e42-1198-4897-bc5e-5bdbe9551d34 37 fields · synced Jul 16, 2026
- EUDAMED c62e567e-0ed6-4255-b2ac-8ee84a133b5e 61 fields · synced Jul 16, 2026