FDA.reportPublic FDA data

ARGENE® CINAkit HCMV ppUL83 US

Primary DI
03573026390273
Brand
ARGENE® CINAkit HCMV ppUL83 US
Company
BIOMERIEUX SA
Model
19-0028US
Device description
Argene CINAKit is intended for use as an aid in the diagnosis of Cytomegalovirus (CMV) infection by the qualitative detection of CMV pp65 antigen by indirect immunofluore scence
Published
2016-10-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GQHAntigen, Cf (Including Cf Control), Cytomegalovirus

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GQHAntigen, Cf (Including Cf Control), CytomegalovirusMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K982311000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K982311000BARTELS CINAKIT CMV ANTIGENEMIAIntracel Corp.1998-12-14GQH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03573026390273PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03573026390273035730263902733573026390273

GMDN Terms#

Term, Definition table
TermDefinition
Cytomegalovirus (CMV) 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 cytomegalovirus (CMV) in a clinical specimen, using a fluorescent immunoassay method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Regulatory Flags#

DUNS number
276816717
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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03573026092009ID color CatalaseID color Catalase2019-07-19
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B0744000160ASTUTE140 Electronic Quality Control (EQC) Device4000164000162016-08-12
B0745000090NEPHROCHECK Calibration Verification (Cal Vers) Kit5000095000092016-08-12
B0745000110NEPHROCHECK Test Kit 5000115000112016-08-12
B0745000130NEPHROCHECK Liquid Control Kit5000135000132016-08-12
03573026547226ETEST® Ertapenem (ETP)ETEST® Ertapenem (ETP)2016-11-18
03573026547271ETEST® Tobramycin (TM)ETEST® Tobramycin (TM)2016-11-18
03573026547295ETEST® Tigecycline (TGC)ETEST® Tigecycline (TGC)2016-11-18
03573026548674ETEST® Ampicillin/sulbactam (2/1) (AB)ETEST® Ampicillin/sulbactam (2/1) (AB)2016-11-18
03573026549046ETEST® Tetracycline (TC)ETEST® Tetracycline (TC)2016-11-18
03573026549077ETEST® Trimethoprim/sulfamethoxazole (1/19) (TS)ETEST® Trimethoprim/sulfamethoxazole (1/19) (TS)2016-11-18
03573026547196ETEST® Fosfomycin (FM)ETEST® Fosfomycin (FM)2016-11-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G5229021111Cytomegalovirus / CMV IgG IFA 96 TestHemagen Diagnostics, Inc.GQH2023-10-06
G5229021121Cytomegalovirus / CMV IgM IFA 96 TestHemagen Diagnostics, Inc.GQH2023-10-06
04053252589768Light Diagnostics CMV Control Slides (5 pack)EMD Millipore CorporationGQH2020-04-17
04053252671074Light Diagnostics CMV IFA ReagentEMD Millipore CorporationGQH2020-04-17
04053252731730Light Diagnostics Anti-mouse IGG:FITCEMD Millipore CorporationGQH2020-04-17
04053252737183Light Diagnostics Mouse Anti-CMV Monoclonal AntibodyEMD Millipore CorporationGQH2020-04-17
04061841047445Light Diagnostics CMV Control SlideEMD Millipore CorporationGQH2020-04-17
04053252676024Light Diagnostics™ CMV IFA KitEMD Millipore CorporationGQH2016-09-26
00813545025489Cytomegalovirus IgG 120 Tests SCIMEDX CORPORATIONGQH2016-09-20
00813545025502Cytomegalovirus 10wl/10 pk SCIMEDX CORPORATIONGQH2016-09-20
B110CM20120Cytomegalovirus Antigen Substrate, 12 wells, For IFA Test SystemBion Enterprises, Ltd.GQH2016-09-12
B110CMG1200CMV IgG Test System, 120 TestsBion Enterprises, Ltd.GQH2016-09-12
B110CMG20200CMV IgG ControlBion Enterprises, Ltd.GQH2016-09-12
B110CMM20300CMV IgM ControlBion Enterprises, Ltd.GQH2016-09-12
B110CMN20100CMV Negative ControlBion Enterprises, Ltd.GQH2016-09-12