Identity
- Trade Name
- Nitro-tab Ketone Tablets FDA UDI
- Generic Name
- Ketone (acetoacetate) IVD, reagent FDA UDI
- Device Name
- Nitro-tab Ketone Tablets are for the semi-quantitative determination of ketones (acetoacetic acid and acetone) in urine, serum, plasma, and whole blood. FDA UDI
- Model / Reference
- 4000-100 FDA UDI
- Description
- Nitro-tab Ketone Tablets are for the semi-quantitative determination of ketones (acetoacetic acid and acetone) in urine, serum, plasma, and whole blood. FDA UDI
Identifiers
- Catalog Number
- 4000-100 FDA UDI
- Primary DI / UDI-DI
- 00657498002131 FDA UDI
- FDA Product Code
- JIN FDA UDI
- GMDN Term
- Ketone (acetoacetate) IVD, reagent FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1435 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
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: Ketone (acetoacetate) IVD, reagent
Nitro-tab Ketone Tablets by Stanbio Laboratory, L.p. — 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
- Stanbio Laboratory, L.p.
Sources (1)
- FDA UDI 869b95de-760c-4a27-bc4a-3c8e49af2e8c 36 fields · synced May 30, 2026