FDA.reportPublic FDA data

LIAISON® Biotrin Control Parvovirus B19 IgG Plus

Primary DI
08056771104036
Brand
LIAISON® Biotrin Control Parvovirus B19 IgG Plus
Company
DIASORIN SPA
Model
311551
Device description
Italy manufactured kit.
Published
2024-04-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MYLAssay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MYLAssay,Enzyme Linked Immunosorbent,Parvovirus B19 IggUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P220034000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P220034000LIAISON Biotrin Parvovirus B19 IgG Plus, LIAISON Biotrin Control Parvovirus B19 IgG PlusDiaSorin, Inc.2024-03-29MYL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08056771104036PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08056771104036080567711040368056771104036

GMDN Terms#

Term, Definition table
TermDefinition
Parvovirus B19 immunoglobulin G (IgG) antibody IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to Parvovirus B19 in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
630822989
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08056771103015LIAISON BRAHMS PCT II GEN3180902018-04-05
08056771104265LIAISON® XL MUREX Anti-HDV3182602026-01-12
08056771104272LIAISON® XL MUREX Control Anti-HDV3182612026-01-12
08056771100199LIAISON® anti-HAV3102002016-09-24
08056771100205LIAISON® Control anti-HAV3102012016-09-24
08056771100571LIAISON® Rubella IgG3104602016-09-24
08056771100588LIAISON® Rubella IgG TRI-Controls3104612016-09-24
08056771100618LIAISON® Treponema Assay3104802016-09-24
08056771102148LIAISON® XLI00502016-09-24
08056771101943LIAISON® CMV IgM3107502016-09-24
08056771102872LIAISON MDXMOL10012017-04-04
08056771102889LIAISON MDXMOL10112017-04-04
08056771103268LIAISON Quantiferon TB Gold Plus3110202019-12-09
08056771104029LIAISON® Biotrin Parvovirus B19 IgG Plus3115502024-04-08
08056771104166LIAISON® VZV IgG HT 3118702024-03-15
08056771104173LIAISON® Control VZV IgG HT 3118712024-03-15
08056771104098LIAISON QUANTIferon TB Gold Plus3110402023-12-14
08056771104081LIAISON QUANTIferon TB Gold Plus3110402023-09-08
08056771200103LIAISON® ENDOCRINOLOGY DILUENT3191332018-09-24
08056771200332LIAISON® CONTROL THYROID 13892192016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08056771104029LIAISON® Biotrin Parvovirus B19 IgG PlusDIASORIN SPAMYL2024-04-08