Identity
- Trade Name
- Poly Rb A-Hu IgA FDA UDI
- Generic Name
- Total immunoglobulin A (IgA total) IVD, antibody FDA UDI
- Device Name
- Polyclonal Rabbit Anti-Human IgA FDA UDI
- Model / Reference
- A0262 FDA UDI
- Description
- Polyclonal Rabbit Anti-Human IgA FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05700572001140 FDA UDI
- FDA Product Code
- CZP FDA UDI
- GMDN Term
- Total immunoglobulin A (IgA total) IVD, antibody FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5510 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
Dimensions & Sizes
- Size
- Total Volume — 1 Milliliter FDA UDI
Category: Total immunoglobulin A (IgA total) IVD, antibody
Poly Rb A-Hu IgA by Agilent Technologies Singapore Pte Ltd — Class II — 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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- Peroxidase conjugated antiserum to Human IgA — KENT LABORATORIES, INC. · Class II
- IgA RID plate package — KENT LABORATORIES, INC. · Class I
- Antiserum to Human IgA (alpha chain specific) — KENT LABORATORIES, INC. · Class II
- Rhodamine conjugated antiserum to Human IgA — KENT LABORATORIES, INC. · Class II
- Rabbit Monoclonal Anti-Human IgA (Heavy Chain) Antibody, EP170 — EPITOMICS, INC. · Class I
- IgA RID plate Kit — KENT LABORATORIES, 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 II | Pending data |
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Manufacturer
- Manufacturer
- Agilent Technologies Singapore Pte Ltd
Sources (1)
- FDA UDI 2ebe50ae-2278-4420-aa4f-4cd659529a30 37 fields · synced Jun 8, 2026