Identity
- Trade Name
- Mission Urinalysis Reagent Strips FDA UDI
- Generic Name
- Urine protein IVD, kit, rapid colorimetric, clinical FDA UDI
- Device Name
- Mission Urinalysis Reagent Strips (PRO) FDA UDI
- Model / Reference
- U031-011 FDA UDI
- Description
- Mission Urinalysis Reagent Strips (PRO) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00682607000371 FDA UDI
- FDA Product Code
- JIR FDA UDI
- GMDN Term
- Urine protein 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
Yes
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 protein IVD, kit, rapid colorimetric, clinical
Mission Urinalysis Reagent Strips by ACON Laboratories, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Rapid Response — BTNX Inc · Class I
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
- ACON Laboratories, Inc.
Sources (1)
- FDA UDI 56c3e3f4-a20d-4483-bed3-0f1005114c11 35 fields · synced Jun 9, 2026