Home GUDID EVIRBBSMPS1 Borrelia B31 IgM ViraStripe® Deca Kit plus
Primary DI EVIRBBSMPS1
Brand Borrelia B31 IgM ViraStripe® Deca Kit plus
Company Viramed Biotech AG
Model V-BBSMPS
Catalog number V-BBSMPS
Device description Immunoassay for the detection of IgM antibodies against Borrelia burgdorferi s.s. / B31 im human serum.
Published 2016-09-26
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name LSR Reagent, Borrelia Serological Reagent
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LSR Reagent, Borrelia Serological Reagent Microbiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status EVIRBBSMPS1 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Borrelia burgdorferi 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 Borrelia burgdorferi in a clinical specimen, using an immunoblot method. The assay is designed to detect infection with Borrelia burgdorferi, the bacteria associated with Lyme disease.
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 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 EVIRBPSADK1 Bordetella pertussis ViraStripe IgA Deca Kit V-BPSADK V-BPSADK 2023-07-17 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 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 00845533002950 Anti-Borrelia VlsE1/pepC10 IgG/IgM ZEUS SCIENTIFIC, INC. LSR 2026-02-18 00850049545259 AccuDiag ™ Diagnostic Automation, Inc. LSR 2024-03-06 00850054026378 QMedix™ Diagnostic Automation, Inc. LSR 2024-01-31 04048474028096 B. burgdorferi IgG/IgM ELISA DRG Instruments Gesellschaft mit beschränkter Haftung LSR 2023-08-29 04048474028102 Borrelia burgdorferi IgG (Lyme) ELISA DRG Instruments Gesellschaft mit beschränkter Haftung LSR 2023-08-29 04048474028119 Borrelia burgdorferi IgM (Lyme) ELISA DRG Instruments Gesellschaft mit beschränkter Haftung LSR 2023-08-29 00840239028099 B. burgdorferi IgG/IgM ELISA DRG International Inc LSR 2023-08-24 00840239028105 Borrelia burgdorferi IgG (Lyme) ELISA DRG International Inc LSR 2023-08-24 00840239028112 Borrelia burgdorferi IgM (Lyme) ELISA DRG International Inc LSR 2023-08-24 EVIRBTCFDK1 Borrelia All-In-One ViraChip Deca Kit Viramed Biotech AG LSR 2022-11-08 EVIRBTCFOK1 Borrelia All-In-One ViraChip Test Kit Viramed Biotech AG LSR 2022-11-08 B350GSD0110310 Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit Gold Standard Diagnostics Corporation LSR 2022-10-28 B350GSD0110250 Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit Gold Standard Diagnostics Corporation LSR 2022-09-24 B350GSD0110260 Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit Gold Standard Diagnostics Corporation LSR 2022-09-24 00845533001854 ELISA Borrelia VlsE1/pepC10 IgG/IgM Smart Kit Test System ZEUS SCIENTIFIC, INC. LSR 2022-04-27 00894175000022 AccuDiag ™ Diagnostic Automation, Inc. LSR 2021-08-10 B350GSD0110270 Gold Standard Diagnostics Borrelia burgdorferi VIsE-OspC ELISA IgG/ IgM Test Kit Gold Standard Diagnostics Corporation LSR 2021-07-20 B350GSD0110220 Gold Standard Diagnostics Borrelia burgdorferi B31 IgG Line Blot Test Kit Gold Standard Diagnostics Corporation LSR 2020-07-01 B350GSD0110230 Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test Kit Gold Standard Diagnostics Corporation LSR 2020-07-01 05391516746779 Trinity Biotech CLARK LABORATORIES, INC. LSR 2019-12-26 05391516746816 Trinity Biotech CLARK LABORATORIES, INC. LSR 2019-12-26 30014613337799 Sofia QUIDEL CORPORATION LSR 2019-12-10 05391516747486 Trinity Biotech CLARK LABORATORIES, INC. LSR 2019-11-05 05391516746625 MarDx CLARK LABORATORIES, INC. LSR 2019-10-25 05391516747134 Trinity Biotech CLARK LABORATORIES, INC. LSR 2019-08-06 05391516747547 Trinity Biotech CLARK LABORATORIES, INC. LSR 2019-08-06 03610520506394 BioPlex 2200 BIO-RAD LABORATORIES, INC. LSR 2019-05-13 03610520506455 BioPlex 2200 BIO-RAD LABORATORIES, INC. LSR 2019-04-30 03610520506462 BioPlex 2200 BIO-RAD LABORATORIES, INC. LSR 2019-04-30 30014613202981 Sofia QUIDEL CORPORATION LSR 2018-08-07
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