FDA UDI
In Commercial Distribution
🇺🇸 United States
Trinity Biotech
DI: 05391516747820
·
Model: 30-7980
·
MARDX DIAGNOSTICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Trinity Biotech
- Primary DI
- 05391516747820
- Version / Model
- 30-7980
- Catalog Number
- 30-7980
- Company Name
- MARDX DIAGNOSTICS, INC.
- Labeler DUNS
- 154281349
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-18
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 7c161436-31f4-4768-8102-8f87dec501c7
Device Description
Legionella IFA Test System,(Legionella species), 180 Tests
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| LHL | Reagents, Antibody, Legionella, Direct & Indirect Fluorescent | Microbiology | 866.3300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 51046 | Legionella longbeachae immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin A (IgA), immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to one or multiple serogroups of Legionella longbeachae bacteria in a clinical specimen, using a fluorescent immunoassay method. The assay is intended to detect infection with Legionella longbeachae, a bacteria associated with Legionnaires' disease. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05391516747820 | GS1 |
Customer Contacts
- Phone
- 800-325-3424
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius