Identity
- Trade Name
- ketodoc B-Ketone Test Strips (40PCS/BOX) FDA UDI
- Generic Name
- Ketone (acetoacetate) IVD, reagent FDA UDI
- Model / Reference
- TD-4141 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00703674534498 FDA UDI
- FDA Product Code
- NBW FDA UDI
- GMDN Term
- Ketone (acetoacetate) IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1345 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
No
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
ketodoc B-Ketone Test Strips (40PCS/BOX) by Rediston Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Ketone (acetoacetate) IVD, reagent.
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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 II | Pending data |
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Manufacturer
- Manufacturer
- Rediston Limited
Sources (1)
- FDA UDI f8b7d8c1-737b-4ad5-889c-70148ef8425e 32 fields · synced Jun 6, 2026