Identity
- Trade Name
- Ketone Urine Controls FDA UDI
- Generic Name
- Multiple urine analyte IVD, control FDA UDI
- Device Name
- Ketone Urine Controls is an assayed urine control intended for use in validating the precision of visual and analyzer reading of urinalysis for one or more of the following analytes: Ascorbic Acid, Glucose, Bilirubin, Ketone (Acetoacetic Acid), Specify Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, Leukocytes and human Chorionic Gonadotropin. FDA UDI
- Model / Reference
- 4020-005 FDA UDI
- Description
- Ketone Urine Controls is an assayed urine control intended for use in validating the precision of visual and analyzer reading of urinalysis for one or more of the following analytes: Ascorbic Acid, Glucose, Bilirubin, Ketone (Acetoacetic Acid), Specify Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, Leukocytes and human Chorionic Gonadotropin. FDA UDI
Identifiers
- Catalog Number
- 4020-005 FDA UDI
- Primary DI / UDI-DI
- 00657498002162 FDA UDI
- FDA Product Code
- JJW FDA UDI
- GMDN Term
- Multiple urine analyte IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 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: Multiple urine analyte IVD, control
Ketone Urine Controls 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 27a29f80-cb5d-4b0d-8a4b-885af6a6aa5c 36 fields · synced Jun 8, 2026