FDA.reportPublic FDA data

Reagent A - CMV Brite™ Turbo kit

Primary DI
08717953022356
Brand
Reagent A - CMV Brite™ Turbo kit
Company
IQ Products B.V.
Model
VIR-CMV110 RA BDC
Catalog number
VIR-CMV110 RA BDC
Device description
Reagent A is a component of the CMV Brite™ Turbo kit which can be used in direct lysis of peripheral blood erythrocytes. This product is registered as “in-vitro diagnostic use only” as a component of the CMV Brite™ Turbo kit with the FDA.
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LINAntisera, Conjugated Fluorescent, Cytomegalovirus

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LINAntisera, Conjugated Fluorescent, CytomegalovirusMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K991650000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K991650000CMV BRITE TURBO KITBiotest Diagnostics Corp.1999-07-12LIN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08717953022356PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08717953022356087179530223568717953022356

GMDN Terms#

Term, Definition table
TermDefinition
Cytomegalovirus (CMV) antigen IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of antigens from cytomegalovirus (CMV) in a clinical specimen.

Storage And Handling#

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

Contacts#

Phone, Email table
PhoneEmail
+31505757000techsupport@iqproducts.nl

Regulatory Flags#

DUNS number
490578678
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08721264790002Anti-HbF R-PEIQP-578RIQP-578R2024-11-13
08719327451007Anti-panHb APCIQP-575AIQP-575A2023-07-19
08719327450949Anti-HbF PUREIQP-567PIQP-567P2023-01-26
08719327450956Anti-HbF FITCIQP-567FIQP-567F2023-01-26
08719327450963Anti-HbF R-PEIQP-567RIQP-567R2023-01-26
08719327450970Anti-HbF Dy-410IQP-567DIQP-567D2023-01-26
08719327450987anti-HbS PUREIQP-574PIQP-574P2023-01-26
08719327450994anti-HbS FITCIQP-574FIQP-574F2023-01-26
08719327451014CD163 PURE IQP-570PIQP-570P2023-01-26
08719327451021CD163 FITCIQP-570FIQP-570F2023-01-26
08719327451038CD163 R-PEIQP-570RIQP-570R2023-01-26
08719327451045CD163 BiotinIQP-570BIQP-570B2023-01-26
08719327451052CD64 PUREIQP-568PIQP-568P2023-01-26
08719327451069CD64 CyQIQP-568CIQP-568C2023-01-26
08719327451076CD64 FITCIQP-568FIQP-568F2023-01-26
08719327451083CD64 R-PEIQP-568RIQP-568R2023-01-26
08719327451090CD64 R-PEIQP-569RIQP-569R2023-01-26
08717953022325CMV Brite™[Only 5 CMV control slides], CMV Antigenemia Test KitVIR-BDC100 CHSVIR-BDC100 CHS2016-09-19
08717953022349CMV Brite™, CMV antigenemia detection kitVIR-BDC100VIR-BDC1002016-09-19
08717953022301CMV Brite™ Turbo, CMV antigenemia detection kitVIR-CMV110 BDCVIR-CMV110 BDC2016-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04053252507397Light Diagnostics CMV DFA ReagentEMD Millipore CorporationLIN2020-04-17
04053252282089Light Diagnostics CMV DFA ReagentEMD Millipore CorporationLIN2020-04-16
30014613330677D3DIAGNOSTIC HYBRIDS, INC.LIN2018-07-20
04053252368745Light Diagnostics™ CMV DFA KitEMD Millipore CorporationLIN2016-09-23
05391516745161Bartels®TRINITY BIOTECH PUBLIC LIMITED COMPANYLIN2016-09-23
05391516745871Bartels®TRINITY BIOTECH PUBLIC LIMITED COMPANYLIN2016-09-23
05391516745888Bartels®TRINITY BIOTECH PUBLIC LIMITED COMPANYLIN2016-09-23
05391516745901Bartels®TRINITY BIOTECH PUBLIC LIMITED COMPANYLIN2016-09-23
08717953022301CMV Brite™ Turbo, CMV antigenemia detection kitIQ Products B.V.LIN2016-09-19
08717953022318CMV Brite™ Turbo Control SlidesIQ Products B.V.LIN2016-09-19
08717953022363Reagent B - CMV Brite™ Turbo kitIQ Products B.V.LIN2016-09-19
08717953022370Reagent C - CMV Brite™ Turbo kitIQ Products B.V.LIN2016-09-19
08717953022387Reagent D - CMV Brite™ Turbo kitIQ Products B.V.LIN2016-09-19
08717953022394Reagent E - CMV Brite™ Turbo kitIQ Products B.V.LIN2016-09-19
08717953022325CMV Brite™[Only 5 CMV control slides], CMV Antigenemia Test KitIQ Products B.V.LIN2016-09-19
08717953022349CMV Brite™, CMV antigenemia detection kitIQ Products B.V.LIN2016-09-19
30014613330660D3DIAGNOSTIC HYBRIDS, INC.LIN2016-09-15