FDA.reportPublic FDA data

Lympholyte-H

Primary DI
00628451099017
Brand
Lympholyte-H
Company
Cedarlane Corporation
Model
CL5010
Catalog number
CL5010
Device description
Lympholyte-H Cell Separation Media (Isolation of lymphocytes from Human peripheral blood), liquid
Published
2024-12-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
JCFLymphocyte Separation Medium

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JCFLymphocyte Separation MediumHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06284510990011PreviousGS10
00628451099017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
06284510990011062845109900116284510990011
00628451099017006284510990176284510990170628451099017

GMDN Terms#

Term, Definition table
TermDefinition
Cell centrifugation/density gradient separation reagent IVDA substance or reactant intended to be used for the isolation of cells from a clinical specimen (e.g., lymphocytes from whole blood, cells from a liquid-based cytology specimen) using centrifugation and density gradient to achieve specimen component separation.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume150Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius25 Degrees Celsius

Regulatory Flags#

DUNS number
243928822
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06284510990387Augurex Life Sciences90-000590-00052022-12-08
06284510990394Augurex Life Sciences90-003890-00382022-12-08
06284510990400Augurex Life Sciences90-002090-00202022-12-08
06284510990417Augurex Life Sciences90-000990-00092022-12-08
06284510990431Augurex Life Sciences90-002190-00212022-12-08
06284510990448Augurex Life Sciences90-003190-00312022-12-08
06284510990455Augurex Life Sciences90-001390-00132022-12-08
06284510990462Augurex Life Sciences90-001590-00152022-12-08
06284510990479Augurex Life Sciences90-001690-00162022-12-08
00628451099062Standard Rabbit ComplementCL3001CL30012024-12-11
00628451099079Standard Rabbit Complement, FrozenCL3005CL30052024-12-11
00628451099086Standard Rabbit ComplementCL3010-10CL3010-102024-12-11
00628451099093Standard Rabbit ComplementCL3010CL30102024-12-11
00628451099109Standard Rabbit ComplementCL3025CL30252024-12-11
00628451099116Standard Rabbit ComplementCL3050CL30502024-12-11
00628451099123Standard Rabbit ComplementCL3111CL31112024-12-11
00628451099130Standard Rabbit ComplementCL3112CL31122024-12-11
00628451099147Standard Rabbit ComplementCL3113CL31132024-12-11
00628451099154Standard Rabbit ComplementCL3115CL31152024-12-11
00628451099161Standard Rabbit ComplementCL3120CL31202024-12-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05407010126969TheraPEAK® T-VIVO® MEDIUM 5L BAGLonza VerviersJCF2025-05-14
05407010125818X-VIVO 10 with Gent and Phenol Red, 1LLonza VerviersJCF2025-02-10
00628451099024Lympholyte-HCedarlane CorporationJCF2024-12-10
00628451099048Lympholyte-HCedarlane CorporationJCF2024-12-10
00628451099482Lympholyte-HCedarlane CorporationJCF2024-12-10
00628451099499Lympholyte-HCedarlane CorporationJCF2024-12-10
05051716000544Leucosep TubesOxford Immunotec, Inc.JCF2023-03-31
05051716000087Leucosep TubesOxford Immunotec, Inc.JCF2023-02-07
05407010124279X-Vivo10 w/o Gent, PR w/ Rec Transf, 1LLonza VerviersJCF2022-12-09
05407010124330X-VIVO 15 w/o PR and Gentamicine 1L bagLonza VerviersJCF2022-12-09
05407010124347X-VIVO 15 w/o PR and Gentamicine 1L bag sampleLonza VerviersJCF2022-12-09
06284510990011Lympholyte-HCedarlane CorporationJCF2022-12-08
06284510990028Lympholyte-HCedarlane CorporationJCF2022-12-08
06284510990042Lympholyte-HCedarlane CorporationJCF2022-12-08
06284510990486Lympholyte-HCedarlane CorporationJCF2022-12-08
06284510990493Lympholyte-HCedarlane CorporationJCF2022-12-08
07540207854158SepMate-15Stemcell Technologies Canada IncJCF2022-10-21
07540207854509SepMate-50Stemcell Technologies Canada IncJCF2022-10-21
17540207854155SepMate-15Stemcell Technologies Canada IncJCF2022-10-21
17540207854506SepMate-50Stemcell Technologies Canada IncJCF2022-10-21
07540207854165SepMate-15Stemcell Technologies Canada IncJCF2022-10-21
07540207854516SepMate-50Stemcell Technologies Canada IncJCF2022-10-21
05407010122565STD X-Vivo 15 w/o gentamicin and pr, 1LLonza VerviersJCF2022-09-12
05407010122572X-Vivo10 w/o Gent, PR w/ Rec Transf, 10LLonza VerviersJCF2022-09-12
05407010122589X-VIVO 15 w/o Gentamycin and PR - 3L bagLonza VerviersJCF2022-09-12
05407010122756X-VIVO 15 w/o PR and Gentamicine 10L bagLonza VerviersJCF2022-09-12
05407010122817TheraPEAK™ X-VIVO™ 15 w REC TRANSF 1LLonza VerviersJCF2022-09-12
05407010122824TheraPEAK X-VIVO10(04-743) contains rec transf -1LLonza VerviersJCF2022-09-12
05407010122831X-VIVO 10 w/o Gentamycin w/o PR, 1LLonza VerviersJCF2022-09-12
05407010122848TheraPEAK™ X-VIVO™ 15 w/o Gent or PR, 1LLonza VerviersJCF2022-09-12