GSD Toxocara canis IgG ELISA GSD01-3000

GUDID B350GSD0130000

Toxocara canis IgG ELISA Test Kit

GOLD STANDARD DIAGNOSTICS CORP.

Toxocara canis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: B350GSD0130000
• NIH Device Record Key: a955a0b7-8a79-4847-8815-c2b09ec39cb6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GSD Toxocara canis IgG ELISA
• Version Model Number: GSD01-3000
• Catalog Number: GSD01-3000
• Company DUNS: 790524891
• Company Name: GOLD STANDARD DIAGNOSTICS CORP.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B350GSD0130000 [Primary]

FDA Product Code

• MDJ: Reagents, Cysticercosis

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-07-12

Devices Manufactured by GOLD STANDARD DIAGNOSTICS CORP.

• B350GSD0110290 - Gold Standard Diagnostics SARS-CoV-2 IgA ELISA Test Kit: 2021-01-12 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 Kit: 2020-09-07 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 Kit: 2020-08-04 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 Kit: 2020-08-04 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 Kit: 2020-08-04 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 Kit: 2020-08-04 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 Kit: 2020-07-28 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 Kit: 2020-07-09 Gold Standard Diagnostics Borrelia burgdorferi B31 IgG Line Blot Test Kit