Home GUDID EVIRBPSADK1 Bordetella pertussis ViraStripe IgA Deca Kit
Primary DI EVIRBPSADK1
Brand Bordetella pertussis ViraStripe IgA Deca Kit
Company Viramed Biotech AG
Model V-BPSADK
Catalog number V-BPSADK
Device description Immunoassay for the detection of IgA antibodies against Bordetella pertussis in human serum.
Published 2023-07-17
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name GOX Antigen, B. Pertussis
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GOX Antigen, B. Pertussis Microbiology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status EVIRBPSADK1 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Bordetella pertussis total antibody IVD, kit, immunoblot A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total antibodies to Bordetella pertussis in a clinical specimen, using an immunoblot method. The assay is designed to detect infection with Bordetella pertussis, the bacteria associated with whooping cough.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 329748847 Device count 1 Premarket exempt true Kit true Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published EVIRBBBGUS1 Borrelia B31 IgG ViraBlot® Test Kit V-BBBGUS V-BBBGUS 2016-09-18 EVIRBBBMUS1 Borrelia B31 IgM ViraBlot® Test Kit V-BBBMUS V-BBBMUS 2016-09-18 EVIRBPSAOK1 Bordetella pertussis ViraStripe IgA Test Kit V-BPSAOK V-BPSAOK 2023-07-17 EVIRBPSGDK1 Bordetella pertussis ViraStripe IgG Deca Kit V-BPSGDK V-BPSGDK 2023-07-17 EVIRBPSGOK1 Bordetella pertussis ViraStripe IgG Test Kit V-BPSGOK V-BPSGOK 2023-07-17 EVIRUVCCAM1 ViraChip Reader V-UVCCAM V-UVCCAM 2023-07-17 EVIRUVCSCA1 ViraChip Scanner V-UVCSCA V-UVCSCA 2023-07-17 EVIRBTCFDK1 Borrelia All-In-One ViraChip Deca Kit V-BTCFDK V-BTCFDK 2022-11-08 EVIRBTCFOK1 Borrelia All-In-One ViraChip Test Kit V-BTCFOK V-BTCFOK 2022-11-08 EVIRBBCGDK1 Borrelia B31 ViraChip IgG Deca Kit V-BBCGDK V-BBCGDK 2018-02-12 EVIRBBCGOK1 Borrelia B31 ViraChip IgG Test Kit V-BBCGOK V-BBCGOK 2017-12-08 EVIRBBCMDK1 Borrelia B31 ViraChip IgM Deca Kit V-BBCMDK V-BBCMDK 2018-02-12 EVIRBBCMOK1 Borrelia B31 ViraChip® IgM Test Kit V-BBCMOK V-BBCMOK 2017-12-08 EVIRBBSGDS1 Borrelia B31 IgG ViraStripe® Deca Kit V-BBSGDS V-BBSGDS 2016-09-18 EVIRBBSGPS1 Borrelia B31 IgG ViraStripe® Deca Kit plus V-BBSGPS V-BBSGPS 2016-09-26 EVIRBBSGUS1 Borrelia B31 IgG ViraStripe® Test Kit V-BBSGUS V-BBSGUS 2016-09-18 EVIRBBSMDS1 Borrelia B31 IgM ViraStripe® Deca Kit V-BBSMDS V-BBSMDS 2016-09-18 EVIRBBSMPS1 Borrelia B31 IgM ViraStripe® Deca Kit plus V-BBSMPS V-BBSMPS 2016-09-26 EVIRBBSMUS1 Borrelia B31 IgM ViraStripe® Test Kit V-BBSMUS V-BBSMUS 2016-09-18
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 04048474061338 Bordetella pertussis Toxin (PT) IgG ELISA DRG Instruments Gesellschaft mit beschränkter Haftung GOX 2023-09-01 04048474034509 Bordetella pertussis IgG ELISA DRG Instruments Gesellschaft mit beschränkter Haftung GOX 2023-08-29 00840239061331 Bordetella pertussis Toxin (PT) IgG ELISA DRG International Inc GOX 2023-08-26 00840239034502 Bordetella pertussis IgG ELISA DRG International Inc GOX 2023-08-24 EVIRBPSAOK1 Bordetella pertussis ViraStripe IgA Test Kit Viramed Biotech AG GOX 2023-07-17 EVIRBPSGDK1 Bordetella pertussis ViraStripe IgG Deca Kit Viramed Biotech AG GOX 2023-07-17 EVIRBPSGOK1 Bordetella pertussis ViraStripe IgG Test Kit Viramed Biotech AG GOX 2023-07-17 00404847461336 Bordetella pertussis Toxin (PT) IgG ELISA DRG Instruments Gesellschaft mit beschränkter Haftung GOX 2021-06-11 00404847434507 Bordetella pertussis IgG ELISA DRG Instruments Gesellschaft mit beschränkter Haftung GOX 2021-06-07 B24220BPGHUE010 Bordetella pertussis IgG ELISA AMERICAN LABORATORY PRODUCTS COMPANY, LTD. GOX 2020-06-18 00382902258513 BD Difco™ Bordetella Pertussis Antigen BECTON, DICKINSON AND COMPANY GOX 2018-05-25 04049016085430 EUROLINE Bordetella pertussis (IgA) EUROIMMUN Medizinische Labordiagnostika AG GOX 2016-09-24 04049016085447 EUROLINE Bordetella pertussis (IgG) EUROIMMUN Medizinische Labordiagnostika AG GOX 2016-09-24 04049016085461 EUROLINE Bordetella pertussis (IgA) EUROIMMUN Medizinische Labordiagnostika AG GOX 2016-09-24 04049016085478 EUROLINE Bordetella pertussis (IgG) EUROIMMUN Medizinische Labordiagnostika AG GOX 2016-09-24 04049016085492 Anti-Bordetella pertussis toxin ELISA (IgA) EUROIMMUN Medizinische Labordiagnostika AG GOX 2016-09-24 04049016085508 Anti-Bordetella pertussis toxin ELISA (IgG) EUROIMMUN Medizinische Labordiagnostika AG GOX 2016-09-24 04049016096047 Anti-Bordetella pertussis ELISA (IgM) EUROIMMUN Medizinische Labordiagnostika AG GOX 2016-09-24 05391516746311 Trinity Biotech MARDX DIAGNOSTICS, INC. GOX 2016-09-18 05391516747868 Trinity Biotech MARDX DIAGNOSTICS, INC. GOX 2016-09-18 05391516747875 Trinity Biotech MARDX DIAGNOSTICS, INC. GOX 2016-09-18 05391516747882 Trinity Biotech MARDX DIAGNOSTICS, INC. GOX 2016-09-18 05391516747899 Trinity Biotech MARDX DIAGNOSTICS, INC. GOX 2016-09-18
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