Identity
- Trade Name
- TECO DIAGNOSTICS FDA UDI
- Generic Name
- Multiple urine analyte IVD, kit, rapid colorimetric, clinical FDA UDI
- Device Name
- URS-2P-100 BOTTLE FDA UDI
- Model / Reference
- URS-2P-100 BOTTLE FDA UDI
- Description
- URS-2P-100 BOTTLE FDA UDI
Identifiers
- Catalog Number
- URS-2P-100B FDA UDI
- Primary DI / UDI-DI
- 10673486000276 FDA UDI
- 510(k) Number
- K955438 FDA UDI
- FDA Product Code
- JIL FDA UDIJIR FDA UDI
- GMDN Term
- Multiple urine analyte IVD, kit, rapid colorimetric, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1340 FDA UDI862.1645 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
Yes
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
Teco Diagnostics by Teco Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Mission Urinalysis Reagent Strips — ACON Laboratories, Inc. · Class II
Cleared under the same submission
K955438 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 II | Pending data |
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Manufacturer
- Manufacturer
- Teco Diagnostics
Sources (1)
- FDA UDI e203f3e9-3d00-4574-bddd-17543bd6c7e5 36 fields · synced May 30, 2026