Identity
- Trade Name
- Lympholyte-H FDA UDI
- Generic Name
- Cell centrifugation/density gradient separation reagent IVD FDA UDI
- Device Name
- Lympholyte-H Cell Separation Media (Isolation of lymphocytes from Human peripheral blood), liquid FDA UDI
- Model / Reference
- CL5020 FDA UDI
- Description
- Lympholyte-H Cell Separation Media (Isolation of lymphocytes from Human peripheral blood), liquid FDA UDI
Identifiers
- Catalog Number
- CL5020 FDA UDI
- Primary DI / UDI-DI
- 06284510990042 FDA UDI
- FDA Product Code
- JCF FDA UDI
- GMDN Term
- Cell centrifugation/density gradient separation reagent IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.8500 FDA UDI
- Commercial Distribution
- Not 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
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 500 Milliliter FDA UDI
Lympholyte-H by Cedarlane Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cedarlane Corporation
Sources (1)
- FDA UDI 49bb3433-0127-4651-b304-6858d4aa6d83 37 fields · synced Jun 6, 2026