Identity
- Trade Name
- Poly Rb A-Hu Kappa LC FDA UDI
- Generic Name
- Kappa/lambda light chain immunoglobulin IVD, antibody FDA UDI
- Device Name
- Polyclonal Rabbit Anti-Human Kappa Light Chains FDA UDI
- Model / Reference
- A0191 FDA UDI
- Description
- Polyclonal Rabbit Anti-Human Kappa Light Chains FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05700572000884 FDA UDI
- FDA Product Code
- DFH FDA UDI
- GMDN Term
- Kappa/lambda light chain immunoglobulin 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
No
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: Kappa/lambda light chain immunoglobulin IVD, antibody
Poly Rb A-Hu Kappa LC by Agilent Technologies Singapore Pte Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Kappa/lambda light chain immunoglobulin IVD, antibody.
- ANTI-LAMBDA LIGHT CHAIN — Biogenex Laboratories, Inc. · Class I
- Rabbit Polyclonal Anti-Human Kappa Light Chain (Polyclonal) Antibody — EPITOMICS, INC. · Class I
- Lambda (EP172) Rabbit Monoclonal Primary Antibody — CELL MARQUE CORPORATION · Class I
- Kappa (EP171) Rabbit Monoclonal Primary Antibody — CELL MARQUE CORPORATION · Class I
- BOND — Leica Biosystems Newcastle, Limited · Class I
- Kappa (EP171) Rabbit Monoclonal Primary Antibody — CELL MARQUE CORPORATION · Class I
- IHC — Slmp, LLC · Class I
- Kappa (M) + Lambda (P) — BIOCARE MEDICAL, LLC · 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 8fd9bdbf-e42b-428f-b5b2-4f2b33762f4a 36 fields · synced Jun 8, 2026