Identity
- Trade Name
- InstaTest FDA UDI
- Generic Name
- Multiple urine analyte IVD, kit, rapid colorimetric, clinical FDA UDI
- Device Name
- InstaTest URS-1P is intended semi-quantitative and qualitative detection of protein in urine. FDA UDI
- Model / Reference
- DACDURS-1P (100) FDA UDI
- Description
- InstaTest URS-1P is intended semi-quantitative and qualitative detection of protein in urine. FDA UDI
Identifiers
- Catalog Number
- URS-1P(100) FDA UDI
- Primary DI / UDI-DI
- 00850049545921 FDA UDI
- FDA Product Code
- JIR FDA UDI
- GMDN Term
- Multiple urine analyte IVD, kit, rapid colorimetric, clinical FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1645 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
Yes
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
InstaTest by Diagnostic Automation, Inc. — 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
- Diagnostic Automation, Inc.
Sources (1)
- FDA UDI 10b92d80-ffff-4a42-aac5-75ec49eca416 37 fields · synced May 30, 2026