Identity
- Trade Name
- IgA RID plate Kit FDA UDI
- Generic Name
- Total immunoglobulin A (IgA total) IVD, antibody FDA UDI
- Device Name
- Radial immunodiffusion plate package for human IgA with three standards FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- Radial immunodiffusion plate package for human IgA with three standards FDA UDI
Identifiers
- Catalog Number
- 102511 FDA UDI
- Primary DI / UDI-DI
- B1761025 FDA UDI
- FDA Product Code
- JZQ FDA UDI
- GMDN Term
- Total immunoglobulin A (IgA total) IVD, antibody FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.4800 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
No
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
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, antibody
IgA RID plate Kit by Kent Laboratories, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total immunoglobulin A (IgA total) IVD, antibody.
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- Poly Rb A-Hu IgA/FITC Rb F(ab')2 — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
- Rabbit Monoclonal Anti-Human IgA (Heavy Chain) Antibody, EP170 — EPITOMICS, INC. · Class I
- IHC — Slmp, LLC · Class I
- Poly Rb A-Hu IgA — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · 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
- Kent Laboratories, Inc.
Sources (1)
- FDA UDI 080b621a-f00d-4425-8bd1-6a6f968d7eae 36 fields · synced May 30, 2026