Identity
- Trade Name
- NIT 1 + NIT 2 FDA UDI
- Generic Name
- Multiple Enterobacteriaceae species culture isolate identification IVD, reagent FDA UDI
- Device Name
- Reagents associated to API 20 E™ (20 100/20 160), API® 10 S (10 100), API® 20 NE (20 050), API® Staph (20 500), API® Coryne (20 900), API® Campy (20 800), ID 32 STAPH (32 500), rapid ID 32 A (32 300) FDA UDI
- Model / Reference
- 70442 FDA UDI
- Description
- Reagents associated to API 20 E™ (20 100/20 160), API® 10 S (10 100), API® 20 NE (20 050), API® Staph (20 500), API® Coryne (20 900), API® Campy (20 800), ID 32 STAPH (32 500), rapid ID 32 A (32 300) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03573026099671 FDA UDI
- FDA Product Code
- JTO FDA UDI
- GMDN Term
- Multiple Enterobacteriaceae species culture isolate identification IVD, reagent FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.2660 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple Enterobacteriaceae species culture isolate identification IVD, reagent
Nit 1 + Nit 2 by Biomerieux , Inc. — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Biomerieux , Inc.
Sources (1)
- FDA UDI 01152db7-1fbe-4b13-badd-d3bf3aca1849 34 fields · synced Jun 6, 2026