Identity
- Trade Name
- Accutest FDA UDI
- Generic Name
- Urine catalase IVD, kit, rapid colorimetric, clinical FDA UDI
- Device Name
- 10-Parameter Urine Reagent Strip (glucose, bilirubin, ketone, S. G., blood, pH, protein, urobilinogen, nitrite & leukocytes) FDA UDI
- Model / Reference
- UA710A FDA UDI
- Description
- 10-Parameter Urine Reagent Strip (glucose, bilirubin, ketone, S. G., blood, pH, protein, urobilinogen, nitrite & leukocytes) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10763924710147 FDA UDI
- 510(k) Number
- K052719 FDA UDI
- FDA Product Code
- JRE FDA UDICDM FDA UDICEN FDA UDIJIN FDA UDIJJB FDA UDIJIO FDA UDIJMT FDA UDILJX FDA UDIJIR FDA UDIJIL FDA UDI
- GMDN Term
- Urine catalase IVD, kit, rapid colorimetric, clinical FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2800 FDA UDI862.1785 FDA UDI862.1550 FDA UDI862.1435 FDA UDI862.1115 FDA UDI864.6550 FDA UDI862.1510 FDA UDI864.7675 FDA UDI862.1645 FDA UDI862.1340 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: Urine catalase IVD, kit, rapid colorimetric, clinical
Accutest by Jant Pharmacal Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Urine catalase IVD, kit, rapid colorimetric, clinical.
- Fisherbrand — FISHER SCIENTIFIC COMPANY L.L.C. · Class I
- Accutest — JANT PHARMACAL CORP. · Class I
- Accustrip Urine Reagent Strip Reader — JANT PHARMACAL CORP. · Class II
- ACCUTEST Uriscreen Rapid Screen for UTI. Test — JANT PHARMACAL CORP. · Class I
- Accustrip 10-Parameter Urine Reagent Strip — JANT PHARMACAL CORP. · Class I
- Accutest — JANT PHARMACAL CORP. · Class I
- Accustrip URS Strips + Reader — JANT PHARMACAL CORP. · Class I
Cleared under the same submission
K052719 also covers:
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
- Jant Pharmacal Corp.
Sources (1)
- FDA UDI 21648e66-1717-43b8-abb3-17fc90ce0a02 34 fields · synced May 31, 2026