GSD Brucella IgG ELISA GSD01-3007

GUDID B350GSD0130070

Brucella IgG ELISA Test Kit

GOLD STANDARD DIAGNOSTICS CORP.

Multiple Brucella species total antibody IVD, kit, enzyme immunoassay (EIA)
Primary Device IDB350GSD0130070
NIH Device Record Key93ac92b5-270c-41a0-9bbb-5e62a96667fa
Commercial Distribution StatusIn Commercial Distribution
Brand NameGSD Brucella IgG ELISA
Version Model NumberGSD01-3007
Catalog NumberGSD01-3007
Company DUNS790524891
Company NameGOLD STANDARD DIAGNOSTICS CORP.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB350GSD0130070 [Primary]

FDA Product Code

GSMAntisera, Fluorescent, Brucella Spp.

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-07-12

Devices Manufactured by GOLD STANDARD DIAGNOSTICS CORP.

B350GSD0110290 - Gold Standard Diagnostics SARS-CoV-2 IgA ELISA Test Kit2021-01-12 Gold Standard Diagnostics SARS-CoV-2 IgA ELISA Test Kit for the qualitative detection of IgA antibodies to SARS-CoV-2 virus to a
B3507203400 - Gold Standard Diagnostics Is-HSV 1&2 IgG ELISA Test Kit2020-09-07 ImmunoSimplicity (Is) HSV 1&2 IgG Test for the detection of IgG antibodies to herpes simplex virus (HSV) type 1 and/or type 2 as
B3507202800 - Gold Standard Diagnostics Is-anti-Scl-70 ELISA Test Kit2020-08-04 ImmunoSimplicity (Is) Anti-Scl-70 ELISA Test Kit for the detection of antibodies against Scl-70 in human serum as an aid in the
B3507203600 - Gold Standard Diagnostics Is-Rubella IgG ELISA Test Kit2020-08-04 ImmunoSimplicity (Is) Rubella IgG ELISA Test Kit for the qualitative and semi-quantitative detection of IgG antibodies to rubell
B3507205400 - Gold Standard Diagnostics Is-Mumps IgG ELISA Test Kit2020-08-04 ImmunoSimplicity (Is) Mumps IgG ELISA Test Kit is for the qualitative and semi-quantitative determination of IgG antibodies to M
B3507206300 - Gold Standard Diagnostics Is-EBNA-1 IgM ELISA Test Kit2020-08-04 ImmunoSimplicity (Is) EBNA-1 IgM ELISA Test Kit for the qualitative determination of IgM antibodies to Epstein-Bar Virus Nuclear
B350GSD0110300 - Gold Standard Diagnostics SARS-CoV-2 IgM ELISA Test Kit2020-07-28 Gold Standard Diagnostics SARS-CoV-2 IgM ELISA Test Kit for the qualitative detection of IgM antibodies to SARS-CoV-2 virus to a
B350GSD0110220 - Gold Standard Diagnostics Borrelia burgdorferi B31 IgG Line Blot Test Kit2020-07-09 Gold Standard Diagnostics Borrelia burgdorferi B31 IgG Line Blot Test Kit

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.