FDA.reportPublic FDA data

Pre-prcs PRTM Frz Sol 131P0103, 50L drum

Primary DI
00840075402589
Brand
Pre-prcs PRTM Frz Sol 131P0103, 50L drum
Company
Lonza Walkersville, Inc.
Model
00190498
Catalog number
00190498
Published
2022-12-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true

Product Codes#

Code, Name table
CodeName
LEAPreservative, Cytological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LEAPreservative, CytologicalPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840075402589PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840075402589008400754025898400754025890840075402589

GMDN Terms#

Term, Definition table
TermDefinition
Ex vivo cell culture mediumA solution used for the ex-vivo culture of human-derived or non-human cells [e.g., T-lymphocytes, mesenchymal stem cells (MSCs), embryonic stem cells, induced pluripotent stem cells (iPSC)] or immortalised cell lines (e.g., HaCat, HeLa, HEK-293, cos-7, PC-12) intended for cell therapy applications. The solution contains a combination of nutrients, which may include amino acids, vitamins and organic salts that are vital for the growth and maintenance of the cell type/line. It is not intended for in vitro fertilization (IVF) or in vitro diagnostic applications.

Regulatory Flags#

DUNS number
609095955
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840075404729TheraPEAK X-VIVO™ 15 without Gentamicin or Phenol Red08-997B2026-05-27
00840075404705CHO Feed Base AWVSP794X202026-05-13
00840075404712CHO Feed Base AWVSP794XSAM2026-05-13
00840075404682CHO Feed Base BWVSP795X202026-03-05
00840075404699CHO Feed Base BWVSP795XSAM2026-03-05
00840075404651CHO Feed Base FWVSP799D2026-02-26
00840075404668CHO Feed Base FWVSP799X202026-02-26
00840075404675CHO Feed Base FWVSP799XSAM2026-02-26
00840075404644X-VIVO 15 without Phenol Red and Gentamicin contains Recombinant TransferrinWVSP1457P1SAMWVSP1457P1SAM2026-02-09
00840075404583GLS CHO Feed FWVSP799B0.5WVSP799B0.52025-12-03
00840075404590GLS CHO Feed FWVSP799B1WVSP799B12025-12-03
00840075404606GLS CHO Feed FWVSP799DWVSP799D2025-12-03
00840075404613GLS CHO Feed FWVSP799JWVSP799J2025-12-03
00840075404620GLS CHO Feed FWVSP799X20WVSP799X202025-12-03
00840075404637GLS CHO Feed FWVSP799XSAMWVSP799XSAM2025-12-03
00840075404545TheraPRO® CHO FeedWVSP1603B1XWVSP1603B1X2025-10-14
00840075404552TheraPRO® CHO FeedWVSP1603BXWVSP1603BX2025-10-14
00840075404569TheraPRO® CHO FeedWVSP1603DXWVSP1603DX2025-10-14
00840075404576TheraPRO® CHO FeedWVSP1603JXWVSP1603JX2025-10-14
00840075404521CHO Feed Base LWVSP906XSAMWVSP906XSAM2025-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10849832027819Leica BiosystemsLeica Biosystems Richmond, Inc.LEA2026-05-22
09551020410030PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410047PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410108PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410115PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410146PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410221PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410238PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410245PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410252PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410283PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410436PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410443PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410450PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410467PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410474PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410481PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410498PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
00613647028629FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.LEA2025-04-30
20613647028623FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.LEA2025-04-30
10849832002946Leica BiosystemsLeica Biosystems Richmond, Inc.LEA2024-12-27
00849832002949Leica BiosystemsLeica Biosystems Richmond, Inc.LEA2024-12-27
00810160180357SUPMEDICSupmedics Inc.LEA2024-11-04
00673693483032EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEA2024-10-22
00673693105279EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEA2024-08-04
00673693105286EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEA2024-08-04
00673693230858EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEA2024-08-04
00673693230865EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEA2024-08-04
00673693344692EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEA2024-08-04
00673693344708EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEA2024-08-04