FDA UDI
In Commercial Distribution
🇺🇸 United States
Trinity Biotech
DI: 05391516747486
·
Model: 2346581
·
CLARK LABORATORIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Trinity Biotech
- Primary DI
- 05391516747486
- Version / Model
- 2346581
- Catalog Number
- 2346581
- Company Name
- CLARK LABORATORIES, INC.
- Labeler DUNS
- 623214079
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-11-05
- Public Version
- 1
- Public Version Date
- 2019-11-13
- Public Version Status
- New
- Public Device Record Key
- b4e1e40c-099c-4bd7-8b53-d7a12166f24e
Device Description
Captia Borrelia burgdorferi IgG/IgM
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| 50568 | Borrelia burgdorferi immunoglobulin G (IgG)/IgM 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 G (IgG) and immunoglobulin M (IgM) antibodies to Borrelia burgdorferi in a clinical specimen, using an enzyme immunoassay (EIA) 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 | 05391516747486 | GS1 |
Customer Contacts
- Phone
- 1-800-325-3424
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K033083 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 480 Tests |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius