FDA.reportPublic FDA data

CAMPY (jcl) Latex 50 Test Kit

Primary DI
00813545026288
Brand
CAMPY (jcl) Latex 50 Test Kit
Company
SCIMEDX CORPORATION
Model
L-CAM01T
Catalog number
L-CAM01T
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

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
K880389000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K880389000MERITEC(TM)-CAMPY (JCL)Meridian Diagnostics, Inc.1988-04-12LQP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813545026288PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813545026288008135450262888135450262880813545026288

GMDN Terms#

Term, Definition table
TermDefinition
Multiple Campylobacter species culture isolate antigen IVD, kit, agglutinationA collection of reagents and other associated materials intended to be used for the qualitative detection of antigens from one or multiple species of Campylobacter bacteria isolated by culture from a clinical specimen, using an agglutination method. Species of Campylobacter bacteria detected may include C. coli, C. fetus and/or C. jejuni.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18002215598service@scimedx.com

Regulatory Flags#

DUNS number
155424708
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
00813545026905MeDiCa1001-481001-482020-11-04
00813545026912MeDiCa1001-961001-962020-11-04
00813545026561MeDiCa010101012020-12-01
00813545026578MeDiCa010201022020-12-01
00813545026776MeDiCa082108212020-12-01
00813545026783MeDiCa082208222020-12-01
00813545026790MeDiCa0821-M0821-M2020-12-01
00813545026806MeDiCa0822-M0822-M2020-12-01
00813545026813MeDiCa083108312020-12-01
00813545026820MeDiCa083208322020-12-01
00813545026837MeDiCa0831-M0831-M2020-12-01
00813545026844MeDiCa0832-M0832-M2020-12-01
00813545026851MeDiCa083308332020-12-01
00813545026868MeDiCa0833-M0833-M2020-12-01
00813545026875MeDiCa083408342020-12-01
00813545026882MeDiCa0834-M0834-M2020-12-01
00813545026899MeDiCa0842-RM0842-M2020-12-01
00813545027223MeDiCa8021-488021-482020-12-01
00813545027261MeDiCa8021-4008021-4002020-12-01
00813545027278MeDiCa8021-96-GI8021-96-GI2020-12-01

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
00857031002455CAMPYLOBACTER QUIK CHEKTECHLAB, INC.LQP2019-04-12
00840733101373ImmunoCard STAT! CAMPYMERIDIAN BIOSCIENCE, INC.LQP2018-08-06