FDA.reportPublic FDA data

CAMPYLOBACTER QUIK CHEK

Primary DI
00857031002455
Brand
CAMPYLOBACTER QUIK CHEK
Company
TECHLAB, INC.
Model
T5047
Device description
The CAMPYLOBACTER QUIK CHEK™ test is a rapid membrane enzyme-linked immunosorbent assay for the qualitative detection of a Campylobacter-specific antigen in human fecal specimens. The CAMPYLOBACTER QUIK CHEK™ test is designed to detect C. jejuni and C. coli from patients with signs and symptoms of gastroenteritis. The test is intended for use with preserved fecal specimens in transport media and unpreserved fecal specimens. Test results should be considered in conjunction with clinical findings and patient history.
Published
2019-04-12
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
LQPCampylobacter Spp.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LQPCampylobacter Spp.Microbiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173217000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173217000CAMPYLOBACTER QUIK CHEKTechlab, Inc.2018-01-22LQP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857031002455PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857031002455008570310024558570310024550857031002455

GMDN Terms#

Term, Definition table
TermDefinition
Multiple Campylobacter species antigen 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 antigens from multiple species of Campylobacter bacteria, which may include C. coli, C. foetus and C. jejuni, 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
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
00857031002417SHIGA TOXIN CHEKT306962019-08-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
30014613338772SofiaQUIDEL CARDIOVASCULAR INC.LQP2025-11-18
50014613338776SofiaQUIDEL CARDIOVASCULAR INC.LQP2025-11-18
05032384519583ProSpecT Campylobacter Microplate Assay 96 TestsOXOID LIMITEDLQP2024-06-20
00840733102387Curian CampyMERIDIAN BIOSCIENCE, INC.LQP2023-03-23
00840733101717PREMIER CAMPYMERIDIAN BIOSCIENCE, INC.LQP2020-09-01
00857031002486CAMPYLOBACTER CHEKTECHLAB, INC.LQP2019-08-06
00857031002578QuickVue TLI Campylobacter TestTECHLAB, INC.LQP2019-05-30
00857031002462CAMPYLOBACTER CHEKTECHLAB, INC.LQP2019-05-29
00857031002479CAMPYLOBACTER QUIK CHEKTECHLAB, INC.LQP2019-05-29
00840733101373ImmunoCard STAT! CAMPYMERIDIAN BIOSCIENCE, INC.LQP2018-08-06
00813545026288CAMPY (jcl) Latex 50 Test Kit SCIMEDX CORPORATIONLQP2016-09-21