Identity
- Trade Name
- JAS Diagnostics FDA UDI
- Generic Name
- Microalbumin IVD, reagent FDA UDI
- Device Name
- Microalbumin Reagent (4 x 20 mL R1, 2 x 10 mL) FDA UDI
- Model / Reference
- MIA2-20 FDA UDI
- Description
- Microalbumin Reagent (4 x 20 mL R1, 2 x 10 mL) FDA UDI
Identifiers
- Catalog Number
- MIA2-20 FDA UDI
- Primary DI / UDI-DI
- 00817274022788 FDA UDI
- FDA Product Code
- DCF FDA UDI
- GMDN Term
- Microalbumin IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
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 — 100 Milliliter FDA UDI
Category: Microalbumin IVD, reagent
JAS Diagnostics by Drew Scientific , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Microalbumin IVD, reagent.
- Alere Afinion™ ACR — Abbott Diagnostics Technologies AS · Class II
- K-ASSAY® Microalbumin Reagent (L) — KAMIYA BIOMEDICAL COMPANY, LLC · Class II
- Afinion ACR — Abbott Diagnostics Technologies AS · Class II
- ClearChem Diagnostics Inc. MicroAlbumin — CLEARCHEM DIAGNOSTICS INC. · Class II
- Pointe Scientific, Inc. Microalbumin — POINTE SCIENTIFIC, INC. · Class II
- K-ASSAY® Microalbumin Reagent — KAMIYA BIOMEDICAL COMPANY, LLC · 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
- Drew Scientific , Ltd.
Sources (1)
- FDA UDI 76b5f771-c4d8-47bd-91ce-861c5df436cf 37 fields · synced May 30, 2026