FDA.reportPublic FDA data

ASCA-CHEK

Primary DI
00857031002325
Brand
ASCA-CHEK
Company
TECHLAB, INC.
Model
T5016
Device description
The ASCA-CHEK test is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of human anti-S. cerevisiae antibodies (ASCA) in feces and serum. The test result is used as an aid in the diagnosis of Crohn’s disease in combination with clinical and other laboratory findings.FOR IN VITRO DIAGNOSTIC USE.
Published
2016-08-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
NBTAntibodies,Saccharomyces Cerevisiae (S.Cerevisiae)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBTAntibodies, Saccharomyces Cerevisiae (S.Cerevisiae)Immunology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857031002325PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857031002325008570310023258570310023250857031002325

GMDN Terms#

Term, Definition table
TermDefinition
Saccharomyces cerevisiae total antibody IVD, kit enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total antibodies to the yeast Saccharomyces cerevisiae in a clinical specimen, using an enzyme immunoassay (EIA) method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
614218634
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857031002547TRI-COMBO PARASITE SCREENT50322019-05-31
00857031002554C. DIFF QUIK CHEK COMPLETET50382019-05-31
00857031002073C. DIFFICILE TOX-B TEST30399U2020-01-24
00857031002530LEUKO EZ VUET50192020-01-24
00857031002561QuickVue TLI H. pylori Test203432019-05-30
00857031002226C. DIFF CHEK - 60T50252019-04-12
00857031002455CAMPYLOBACTER QUIK CHEKT50472019-04-12
00857031002301CRYPTOSPORIDIUM IIPT50142016-08-23
00857031002523H. PYLORI CHEK309962018-09-28
00857031002356LACTOFERRIN EZ VUET50182019-05-31
00857031002585QuickVue TLI Lactoferrin Test203452019-05-30
00857031002189LACTOFERRIN EZ VUE303532019-05-29
00857031002172LEUKO EZ VUET303552019-04-12
00857031002646C. DIFFICILE TOX A/B IIT5015XB2021-05-07
00857031002660C. DIFF CHEK - 60TL50252021-05-03
00857031002639H. PYLORI CHEK T5051B2021-03-12
00857031002066C. DIFFICILE TOXIN ANTITOXIN KITT50002020-01-24
00857031002264C. DIFFICILE TOX-B TESTT50032020-01-24
00857031002622QuickVue TLI H. pylori Stool Antigen Test203432019-09-26
00857031002196SHIGA TOXIN QUIK CHEKT306252019-08-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250289503143AESKULISA® ASCA-A Aesku.Diagnostics GmbH & Co. KGNBT2017-03-17
04250289503150AESKULISA® ASCA-G Aesku.Diagnostics GmbH & Co. KGNBT2017-03-17
04250289502894AESKULISA® ASCA-A Aesku.Diagnostics GmbH & Co. KGNBT2017-02-28
04250289502900AESKULISA® ASCA-G Aesku.Diagnostics GmbH & Co. KGNBT2017-02-28
04250289501521AESKULISA® ASCA-A Aesku.Diagnostics GmbH & Co. KGNBT2016-09-27
04250289501538AESKULISA® ASCA-G Aesku.Diagnostics GmbH & Co. KGNBT2016-09-27
00847817018534Autoimmune EIABIO-RAD LABORATORIES, INC.NBT2016-09-12
00847817018541Autoimmune EIABIO-RAD LABORATORIES, INC.NBT2016-09-12
08426950514206QUANTA Lite® ASCA IgG ELISAINOVA DIAGNOSTICS, INC.NBT2016-08-31
08426950514213QUANTA Lite® ASCA IgA ELISAINOVA DIAGNOSTICS, INC.NBT2016-08-31