Identity
- Trade Name
- TestOxidase Reagent (125ml) FDA UDI
- Generic Name
- Indole/Kovac's microbial reagent IVD FDA UDI
- Device Name
- TestOxidase™ Reagent is a qualitative method for the determination of bacterial cytochrome oxidase. FDA UDI
- Model / Reference
- PL.390-125 FDA UDI
- Description
- TestOxidase™ Reagent is a qualitative method for the determination of bacterial cytochrome oxidase. FDA UDI
Identifiers
- Catalog Number
- PL.390-125 FDA UDI
- Primary DI / UDI-DI
- 10628429000998 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
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
No
FDA UDI
Category: Indole/Kovac's microbial reagent IVD
TestOxidase Reagent (125ml) by Pro-Lab, Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Indole/Kovac's microbial reagent IVD.
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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
- Pro-Lab, Incorporated
Sources (1)
- FDA UDI c37275e2-267a-4e02-bbc8-0c011ab1c5f1 34 fields · synced May 30, 2026