FDA.reportPublic FDA data

IMAGEN Chlamydia

Primary DI
05032384502943
Brand
IMAGEN Chlamydia
Company
OXOID LIMITED
Model
K610111-2
Published
2024-06-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LJPAntiserum, Fluorescent, Chlamydia Trachomatis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LJPAntiserum, Fluorescent, Chlamydia TrachomatisMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05032384502943PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05032384502943050323845029435032384502943

GMDN Terms#

Term, Definition table
TermDefinition
Multiple Chlamydia species antigen IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from multiple species of Chlamydia bacteria in a clinical specimen, using a fluorescent immunoassay method.

Regulatory Flags#

DUNS number
365355452
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05032384029600ANAEROJAR BASEAG0026A2022-12-12
05032384029044STAPHYTECT PLUSDR0850M2026-01-28
05032384029051STAPHYTECT PLUSDR0850B2026-01-28
05032384550784Thermo Scientific Oxoid Gepotidacin Disc (10 ug) GEP10CT1975B2026-01-21
05032384533121Oxoid Aztreonam/Avibactam Disc (30/20ug) AZA50CT1971B2025-12-12
05032384003914SELENITE CYST.BROTH BASECM0699B2025-07-23
05032384126453PEPTONE WATER (ANDRADE)CM0061B2025-06-27
05032384127993REAGENT SPOT INDOLE DMACAMB1448A2025-06-27
05032384502974IMAGEN Parainfluenza Virus Types 1, 2 and 3K610411-22024-12-30
05032384502981IMAGEN Influenza Virus A and BK610511-22024-12-30
05032384012039AMPICILLIN SELECTIVE SUPP. 1 X 10 VIALSSR0136E2022-12-02
05032384082919ORSAB SELECTIVE SUPPLEMENTSR0195E2024-10-29
05032384083237OXACILLIN RES. SCREENING AGAR BASECM1008B2024-10-29
05032384516018Oxoid Eravacycline Disc (20ug) ERV20 Antimicrobial Susceptibility Test DiscsCT1954B2024-10-28
05032384537723Oxoid Sulbactam/Durlobactam (10/10ug) SUD20 Antimicrobial Susceptibility Test DiCT1960B2024-10-28
05032384128006Microbact Staph 12SMB1561A2024-10-28
05032384128013Microbact Staph Fast Blue ReagentMB1588A2024-10-28
05032384580231Oxoid Eravacycline Disc (20ug) ERV20 Antimicrobial Susceptibility Test DiscsCT1954B2024-10-28
05032384579945Oxoid Sulbactam/Durlobactam (10/10ug) SUD20 Antimicrobial Susceptibility Test DiCT1960B2024-10-28
05700573075706NAK610611-22016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05032384503032IMAGEN CHLAMYDIA POSITIVE CONTROL SLIDEOXOID LIMITEDLJP2024-07-03
G5229030001Chlamydia trachomatis / C. trach IgG IFA 96 TestHemagen Diagnostics, Inc.LJP2023-10-05
G5229030011Chlamydia trachomatis / C. trach IgG IFA Slide Only KitHemagen Diagnostics, Inc.LJP2023-10-05
00847865001410PathfinderBio-RAD Laboratories, Inc.LJP2023-01-04
00847865001427PathfinderBio-RAD Laboratories, Inc.LJP2023-01-04
00847865001434PathfinderBio-RAD Laboratories, Inc.LJP2023-01-04
00847865001441PathfinderBio-RAD Laboratories, Inc.LJP2023-01-04
00847865012775PathfinderBio-RAD Laboratories, Inc.LJP2023-01-04
05056080501901PathoDx Chlamydia trachomatis Control SlideREMEL EUROPE LIMITEDLJP2021-07-21
05056080501918PathoDx Chlamydia Culture ConfirmationREMEL EUROPE LIMITEDLJP2021-07-21
05056080501925PathoDx Chlamydia trachomatis Direct SpecimenREMEL EUROPE LIMITEDLJP2021-07-21
30014613330547D3DIAGNOSTIC HYBRIDS, INC.LJP2018-08-30
30014613330554D3DIAGNOSTIC HYBRIDS, INC.LJP2018-07-22