FDA.reportPublic FDA data

IMAGEN PARAINFLUENZA VIRUS TYPES 1, 2, 3

Primary DI
05032384502967
Brand
IMAGEN PARAINFLUENZA VIRUS TYPES 1, 2, 3
Company
OXOID LIMITED
Model
K610311-2
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
GQSAntigens, Cf (Including Cf Control), Parainfluenza Virus 1-4

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GQSAntigens, Cf (Including Cf Control), Parainfluenza Virus 1-4Microbiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05032384502967PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05032384502967050323845029675032384502967

GMDN Terms#

Term, Definition table
TermDefinition
Multiple human parainfluenza virus 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 strains of human parainfluenza virus 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
05032384502974IMAGEN Parainfluenza Virus Types 1, 2 and 3OXOID LIMITEDGQS2024-12-30
30014613330844D3 FastpointDIAGNOSTIC HYBRIDS, INC.GQS2019-03-07
30014613330851D3 FastpointDIAGNOSTIC HYBRIDS, INC.GQS2019-03-07
30014613330868D3 FastpointDIAGNOSTIC HYBRIDS, INC.GQS2019-03-07
30014613330875D3 FastpointDIAGNOSTIC HYBRIDS, INC.GQS2019-03-07
30014613330769D3 FastpointDIAGNOSTIC HYBRIDS, INC.GQS2018-07-22
30014613330776D3 FastpointDIAGNOSTIC HYBRIDS, INC.GQS2018-07-22
30014613330752D3 FastpointDIAGNOSTIC HYBRIDS, INC.GQS2016-09-15