FDA UDI
In Commercial Distribution
🇺🇸 United States
Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit
DI: B350GSD0110260
·
Model: GSD01-1026
·
Gold Standard Diagnostics Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit
- Primary DI
- B350GSD0110260
- Version / Model
- GSD01-1026
- Catalog Number
- GSD01-1026
- Company Name
- Gold Standard Diagnostics Corporation
- Labeler DUNS
- 790524891
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-24
- Public Version
- 1
- Public Version Date
- 2022-10-03
- Public Version Status
- New
- Public Device Record Key
- c94b90c1-c15a-447f-b52c-858057827f8b
Device Description
Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit
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 |
|---|---|---|---|---|
| LSR | Reagent, Borrelia Serological Reagent | Microbiology | 866.3830 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 50555 | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B350GSD0110260 | HIBCC |
Premarket Submissions
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius