Identity
- Trade Name
- Poly Rb A-Hu IgM/HRP FDA UDI
- Generic Name
- Total immunoglobulin M (IgM total) IVD, antibody FDA UDI
- Device Name
- Polyclonal Rabbit Anti-Human IgM/HRP FDA UDI
- Model / Reference
- P0215 FDA UDI
- Description
- Polyclonal Rabbit Anti-Human IgM/HRP FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05700572007364 FDA UDI
- FDA Product Code
- DEY FDA UDI
- GMDN Term
- Total immunoglobulin M (IgM total) IVD, antibody FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5550 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 — 2 Milliliter FDA UDI
Category: Total immunoglobulin M (IgM total) IVD, antibody
Poly Rb A-Hu IgM/HRP 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 M (IgM total) IVD, antibody.
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- IHC — Slmp, LLC · Class I
- IgM RID plate package — KENT LABORATORIES, INC. · Class II
- Peroxidase conjugated antiserum to Human IgM — KENT LABORATORIES, INC. · Class II
- BOND — Leica Biosystems Newcastle, Limited · Class I
- IHC — Slmp, LLC · Class I
- IgM — Randox Laboratories, 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 II | Pending data |
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Manufacturer
- Manufacturer
- Agilent Technologies Singapore Pte Ltd
Sources (1)
- FDA UDI 16a03288-6b3a-40b3-9d55-3338b8329a61 36 fields · synced May 30, 2026