Gold Standard Diagnostics Borrelia burgodorferi B3 GSD01-1018

GUDID B350GSD0110180

Gold Standard Diagnostics Borrelia burgodorferi B31 IgG Line Blot Test Kit

GOLD STANDARD DIAGNOSTICS CORP.

Borrelia burgdorferi total antibody IVD, kit, immunoblot
Primary Device IDB350GSD0110180
NIH Device Record Key0ae3d8bc-f8f5-42b9-b674-dc5859e4b2dd
Commercial Distribution Discontinuation2018-03-30
Commercial Distribution StatusNot in Commercial Distribution
Brand NameGold Standard Diagnostics Borrelia burgodorferi B3
Version Model NumberGSD01-1018
Catalog NumberGSD01-1018
Company DUNS790524891
Company NameGOLD STANDARD DIAGNOSTICS CORP.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB350GSD0110180 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LSRReagent, Borrelia Serological Reagent

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2016-09-20

On-Brand Devices [Gold Standard Diagnostics Borrelia burgodorferi B3]

B350GSD1010220Gold Standard Diagnostics Borrelia burgodorferi B31 IgG Line Blot Test Kit - 10 Pack
B350GSD0610190Gold Standard Diagnostics Borrelia burgodorferi B31 IgM Line Blot Test Kit - Bulk
B350GSD0610180Gold Standard Diagnostics Borrelia burgodorferi B31 IgG Line Blot Test Kit - Bulk
B350GSD0110180Gold Standard Diagnostics Borrelia burgodorferi B31 IgG Line Blot Test Kit

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