FDA.reportPublic FDA data

Marketlab, Inc

Primary DI
00817517026825
Brand
Marketlab, Inc
Company
MARKETLAB INC.
Model
691930
Published
2023-03-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
KETFilters, Cell Collection, Tissue Processing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KETFilters, Cell Collection, Tissue ProcessingPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817517026825PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817517026825008175170268258175170268250817517026825

GMDN Terms#

Term, Definition table
TermDefinition
Histological tissue cassette biopsy insert IVDA flexible and porous material designed to securely hold a biopsy specimen within a tissue cassette, to prevent loss of the specimen during laboratory specimen processing (e.g., fixation, dehydration, infiltration) in preparation for subsequent cytological or histological examination. The flexible and porous material (e.g., paper, synthetic polymer) is intended to allow infiltration of reagents and maximize fluid-exchange during tissue processing. It is available in various forms (e.g., sheet, bag, foam pad) and is placed in a tissue processing cassette, with the biopsy specimen wrapped or contained inside it. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
848917027
Device count
1
Premarket exempt
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817518024523MarketLab, Inc.1087812025-12-18
00817643023972Hopkins1380422024-02-02
00817517027938Marketlab-Clinton1387632024-02-02
00817517027945Marketlab-Clinton1387642024-02-02
00817517027952Marketlab-Clinton1387652024-02-02
00817517027969Marketlab-Clinton1387662024-02-02
00817517027976Marketlab-Clinton1387672024-02-02
00817517027983Marketlab-Clinton1387682024-02-02
00817517027990Marketlab-Clinton1387692024-02-02
00817517028003Marketlab-Clinton1387702024-02-02
00817517028072Marketlab-Clinton1387712024-02-02
00817517028089Marketlab-Clinton1387722024-02-02
00817517028096Marketlab-Clinton1387732024-02-02
00817517028102Marketlab-Clinton1387742024-02-02
00817517028119Marketlab-Clinton1387752024-02-02
00817517028126Marketlab-Clinton1387762024-02-02
00817517028133Marketlab-Clinton1387772024-02-02
00817517028140Marketlab-Clinton1387782024-02-02
00817517028157Marketlab-Clinton1387792024-02-02
00817517028164Marketlab-Clinton1387802024-02-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09551020410078PathTezt®BIOCYTECH CORPORATION SDN. BHD.KET2026-03-11
09551020410085PathTezt®BIOCYTECH CORPORATION SDN. BHD.KET2026-03-11
09551020410313PathTezt®BIOCYTECH CORPORATION SDN. BHD.KET2026-03-11
09551020410504PathTezt®BIOCYTECH CORPORATION SDN. BHD.KET2026-03-11
09551020410511PathTezt®BIOCYTECH CORPORATION SDN. BHD.KET2026-03-11
04260649292075cytoQ®SABEU GmbH & Co. KGKET2026-02-10
04260649292099cytoQ®SABEU GmbH & Co. KGKET2026-02-10
04260649292112cytoQ®SABEU GmbH & Co. KGKET2026-02-10
04260649292068cytoQ®SABEU GmbH & Co. KGKET2026-02-10
04260649292082cytoQ®SABEU GmbH & Co. KGKET2026-02-10
04260649292105cytoQ®SABEU GmbH & Co. KGKET2026-02-10
07898027900792CELLPRESERV KOLPLASTKolplast C IKET2023-11-29
00630094188508Bioseal Inc.BIOSEALKET2023-10-05
00630094188515Bioseal Inc.BIOSEALKET2023-10-05
00630094188607Bioseal Inc.BIOSEALKET2023-10-05
00630094887029Bioseal Inc.BIOSEALKET2023-10-05
00630094889054Bioseal Inc.BIOSEALKET2023-10-05
10630094188505Bioseal Inc.BIOSEALKET2023-10-05
10630094188512Bioseal Inc.BIOSEALKET2023-10-05
10630094188604Bioseal Inc.BIOSEALKET2023-10-05
10630094887026Bioseal Inc.BIOSEALKET2023-10-05
10630094889051Bioseal Inc.BIOSEALKET2023-10-05
00853778007005Double Cytology Funnel w/ White Card and CapsBiomedical Polymers, Inc.KET2023-08-21
00853778007135BMP Medical Single Cytology Funnel w/ White CardBiomedical Polymers, Inc.KET2023-08-21
00853778007142Single Cytology Funnel w/ Brown CardBiomedical Polymers, Inc.KET2023-08-21
00853778007159BMP Medical Metal Cytology ClipBiomedical Polymers, Inc.KET2023-08-21
20853778007009Double Cytology Funnel w/ White Card and CapsBiomedical Polymers, Inc.KET2023-08-21
10853778007132BMP Medical Single Cytology Funnel w/ White CardBiomedical Polymers, Inc.KET2023-08-21
10853778007149Single Cytology Funnel w/ Brown CardBiomedical Polymers, Inc.KET2023-08-21
10853778007156BMP Medical Metal Cytology ClipBiomedical Polymers, Inc.KET2023-08-21