FDA.reportPublic FDA data

CMV Brite™ Turbo, CMV antigenemia detection kit

Primary DI
08717953022301
Brand
CMV Brite™ Turbo, CMV antigenemia detection kit
Company
IQ Products B.V.
Model
VIR-CMV110 BDC
Catalog number
VIR-CMV110 BDC
Device description
The CMV Brite™ Turbo Kit is intended for the qualitative detection of Cytomegalovirus (CMV) lower matrix protein pp65 by indirect immunofluorescence in isolated peripheral blood leukocytes obtained from EDTA and heparin anticoagulated human peripheral blood. The detection of CMV pp65 in human leukocytes aids in the diagnosis of acute or reactivated CMV infection.
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
08717953022301PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08717953022301087179530223018717953022301

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

Contacts#

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

Regulatory Flags#

DUNS number
490578678
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
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
08717953022318CMV Brite™ Turbo Control SlidesVIR-CMV CS05 BDCVIR-CMV CS05 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
08717953022318CMV Brite™ Turbo Control SlidesIQ Products B.V.LIN2016-09-19
08717953022356Reagent A - CMV Brite™ Turbo kitIQ 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