Identity
- Trade Name
- ClearChem Diagnostics Inc. MicroProtein, Total FDA UDI
- Generic Name
- Total microprotein IVD, reagent FDA UDI
- Device Name
- In Vitro Diagnostics testing kit R1:4X60mL, STD 1X15mL FDA UDI
- Model / Reference
- MPN2020 FDA UDI
- Description
- In Vitro Diagnostics testing kit R1:4X60mL, STD 1X15mL FDA UDI
Identifiers
- Catalog Number
- MPN2020 FDA UDI
- Primary DI / UDI-DI
- 00852169008294 FDA UDI
- FDA Product Code
- JGP FDA UDIJIX FDA UDI
- GMDN Term
- Total microprotein IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1635 FDA UDI862.1150 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
Dimensions & Sizes
- Size
- Total Volume — 255 Milliliter FDA UDI
Category: Total microprotein IVD, reagent
ClearChem Diagnostics Inc. MicroProtein, Total by Clearchem Diagnostics Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total microprotein IVD, reagent.
- Pointe Scientific, Inc. Microprotein — POINTE SCIENTIFIC, INC. · Class II
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC. · Class II
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
- Clearchem Diagnostics Inc.
Sources (1)
- FDA UDI a8b5d200-27d7-4902-8a6a-06f959b33ce6 37 fields · synced May 30, 2026