Identity
- Trade Name
- TopCare FDA UDI
- Generic Name
- Multiple urine analyte IVD, kit, rapid colorimetric, clinical FDA UDI
- Device Name
- OTC Single Use urinary test strip FDA UDI
- Model / Reference
- UTES FDA UDI
- Description
- OTC Single Use urinary test strip FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00036800468450 FDA UDI
- 510(k) Number
- K063295 FDA UDI
- FDA Product Code
- LJX FDA UDIJMT FDA UDI
- GMDN Term
- Multiple urine analyte IVD, kit, rapid colorimetric, clinical FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.7675 FDA UDI862.1510 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: Multiple urine analyte IVD, kit, rapid colorimetric, clinical
TopCare by Reese Pharmaceutical Company — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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
- Reese Pharmaceutical Company
Sources (1)
- FDA UDI 4bdb2de5-a863-4688-9002-c0c4dcb77a2f 35 fields · synced May 30, 2026