Identity
- Trade Name
- Accustrip URS Strips + Reader FDA UDI
- Generic Name
- Urine catalase IVD, kit, rapid colorimetric, clinical FDA UDI
- Device Name
- Accustrip URS 10 parameter Strips and Accustrip URS Reader FDA UDI
- Model / Reference
- UA897 FDA UDI
- Description
- Accustrip URS 10 parameter Strips and Accustrip URS Reader FDA UDI
Identifiers
- Primary DI / UDI-DI
- 20763924897104 FDA UDI
- FDA Product Code
- JRE FDA UDICDM FDA UDIJIR FDA UDICEN FDA UDIJMT FDA UDIJIN FDA UDIJIL FDA UDIJJB FDA UDILJX FDA UDIJIO 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 UDI862.1645 FDA UDI862.1550 FDA UDI862.1510 FDA UDI862.1435 FDA UDI862.1340 FDA UDI862.1115 FDA UDI864.7675 FDA UDI864.6550 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Urine catalase IVD, kit, rapid colorimetric, clinical
Accustrip URS Strips + Reader 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
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- 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
Cleared under the same submission
K061742 also covers:
K991927 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 |
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Manufacturer
- Manufacturer
- Jant Pharmacal Corp.
Sources (1)
- FDA UDI f0907d67-92ec-4cbe-afea-d17386dffbfd 34 fields · synced May 30, 2026