Identity
- Trade Name
- Northeast Laboratory Services FDA UDI
- Generic Name
- Indole/Kovac's microbial reagent IVD FDA UDI
- Device Name
- Kovac's Reagent FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- Kovac's Reagent FDA UDI
Identifiers
- Catalog Number
- X1150 FDA UDI
- Primary DI / UDI-DI
- 00810144911236 FDA UDI
- FDA Product Code
- JTO FDA UDI
- GMDN Term
- Indole/Kovac's microbial reagent IVD 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
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
No
FDA UDI
Category: Indole/Kovac's microbial reagent IVD
Northeast Laboratory Services by Northeast Laboratory Services, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Indole/Kovac's microbial reagent IVD.
- BD BBL™ DMACA Indole Reagent Droppers — BECTON DICKINSON AND COMPANY · Class I
- BD BBL™ Indole Reagent Droppers — BECTON DICKINSON AND COMPANY · Class I
- BD BBL™ DrySlide™ Indole — BECTON DICKINSON AND COMPANY · Class I
- TestOxidase Reagent (125ml) — PRO-LAB, INCORPORATED · Class I
- TestOxidase Reagent (15ml) — PRO-LAB, INCORPORATED · Class I
- Kovac's Reagent (100ml) — PRO-LAB, INCORPORATED · Class I
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
- Northeast Laboratory Services, Inc.
Sources (1)
- FDA UDI efb86f1f-a119-4eb2-8764-0be14a9dc5c3 34 fields · synced May 30, 2026