Identity
- Trade Name
- Anti-Human IgA - Particle - ASR pack FDA UDI
- Generic Name
- Total immunoglobulin A (IgA total) IVD, reagent FDA UDI
- Model / Reference
- MA010 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05051700020329 FDA UDI
- FDA Product Code
- MVU FDA UDI
- GMDN Term
- Total immunoglobulin A (IgA total) IVD, reagent FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.4020 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
Category: Total immunoglobulin A (IgA total) IVD, reagent
Anti-Human IgA - Particle - ASR pack by The Binding Site Group — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total immunoglobulin A (IgA total) IVD, reagent.
- K-ASSAY® IgA 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 I | Pending data |
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Manufacturer
- Manufacturer
- The Binding Site Group
Sources (1)
- FDA UDI d7322c4b-d724-434d-a3bd-88c6cc94f320 34 fields · synced May 30, 2026