FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Gold Standard Diagnostics SARS-CoV-2 IgA ELISA Test Kit
DI: B350GSD0110290
·
Model: GSD01-1029
·
Gold Standard Diagnostics Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Gold Standard Diagnostics SARS-CoV-2 IgA ELISA Test Kit
- Primary DI
- B350GSD0110290
- Version / Model
- GSD01-1029
- Catalog Number
- GSD01-1029
- Company Name
- Gold Standard Diagnostics Corporation
- Labeler DUNS
- 790524891
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-05-20
- Public Version
- 3
- Public Version Date
- 2021-06-04
- Public Version Status
- Update
- Public Device Record Key
- 7e09f02b-42a7-49f4-85f2-980cb45e1464
- Distribution End Date
- 2020-12-11
Device Description
Gold Standard Diagnostics SARS-CoV-2 IgA ELISA Test Kit for the qualitative detection of IgA antibodies to SARS-CoV-2 virus to aid in the diagnosis of Coronavirus (COVID-19).
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QJR | Reagents, 2019-Novel Coronavirus Nucleic Acid | Unknown | N |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64830 | SARS-CoV-2 immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin A (IgA) antibodies to severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2) in a clinical specimen, using an enzyme immunoassay (EIA) method. This test is used to aid the diagnosis of coronavirus disease (COVID-19) infection. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B350GSD0110290 | HIBCC |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius