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Lympholyte-H

FDA UDI

Class I (US FDA UDI)

by Cedarlane Corporation

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
00628451099048 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
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

Category: Cell centrifugation/density gradient separation reagent IVD

Lympholyte-H by Cedarlane Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cell centrifugation/density gradient separation reagent IVD.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cedarlane Corporation

Sources (1)

  • FDA UDI 5319498c-df57-4eb7-a23f-512766656e0c 36 fields · synced May 30, 2026