FDA.reportPublic FDA data

Bartels®

Primary DI
05391516745871
Brand
Bartels®
Company
TRINITY BIOTECH PUBLIC LIMITED COMPANY
Model
B1029-81
Catalog number
B1029-81
Device description
Bartels® CMV Fluorescent Antibody Test
Published
2016-09-23
Public version status
Update
Distribution status
Not 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
K894002000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K894002000CYTOMEGALOVIRUS FLUORESCENT MONOCLONAL ANTIBODYBaxter Healthcare Corp1989-08-10LIN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391516745871PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391516745871053915167458715391516745871

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+35312769800Infectiousdisease.techsupport@trinitybiotech.com

Regulatory Flags#

DUNS number
988298840
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
05391516741927Trinity Biotech450-A450-A2016-09-23
05391516742238Trinity Biotech591-C591-C2017-10-06
05391516742245Trinity Biotech591-D 591-D 2017-10-06
05391516746106Uni-Gold™ 120650612065062016-09-23
05391516746113Uni-Gold™ 120653012065302016-09-23
05391516742290Trinity Biotech 826-10826-102016-09-23
05391516745161Bartels®B1029-81AB1029-81A2016-09-23
05391516745826Bartels®B1029-44B1029-442016-09-23
05391516745864Bartels® B1029-44CB1029-44C2016-09-23
05391516745888Bartels®B1029-81BB1029-81B2016-09-23
05391516745901Bartels®B1029-91B1029-912016-09-23
05391516745918Bartels®B1029-47B1029-472016-09-23
05391516745925Bartels®B1029-47CB1029-47C2016-09-23
05391516745932Bartels®B1029-48B1029-482016-09-23
05391516745949Bartels® B1029-47BB1029-47B2016-09-23
05391516746007MicroTrak®8H219UL8H219UL2016-09-23
05391516746038MicroTrak®8H349UL 8H349UL 2016-09-23
05391516746144MicroTrak®8H399UL8H399UL2016-09-23
05391516748643MicroTrak®8H329UL8H329UL2016-09-23
05391516741521Trinity Biotech203-A203-A2016-09-23

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
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
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