Identity
- Trade Name
- IFE Free Lambda Light Chain Antiserum FDA UDI
- Generic Name
- Kappa/lambda light chain immunoglobulin IVD, antibody FDA UDI
- Model / Reference
- 9413 FDA UDI
Identifiers
- Primary DI / UDI-DI
- M52594130 FDA UDI
- 510(k) Number
- K891683 FDA UDI
- FDA Product Code
- CZN FDA UDI
- GMDN Term
- Kappa/lambda light chain immunoglobulin 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
Category: Kappa/lambda light chain immunoglobulin IVD, antibody
IFE Free Lambda Light Chain Antiserum by Helena Laboratories, Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Kappa/lambda light chain immunoglobulin IVD, antibody.
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- Lambda (EP172) Rabbit Monoclonal Primary Antibody — CELL MARQUE CORPORATION · Class I
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- FLEX Poly Rb A-Hu Lambda LC RTU (Dako Omnis) — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
- BOND — Leica Biosystems Newcastle, Limited · Class I
- Kappa (EP171) Rabbit Monoclonal Primary Antibody — CELL MARQUE CORPORATION · Class I
Cleared under the same submission
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
- Helena Laboratories, Corp.
Sources (1)
- FDA UDI e9d8ac2f-db8c-4e80-881c-c8886e376e37 34 fields · synced Jun 9, 2026