FDA UDI
In Commercial Distribution
🇺🇸 United States
Trinity Biotech
DI: 05391516747851
·
Model: 40-3025G
·
MARDX DIAGNOSTICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Trinity Biotech
- Primary DI
- 05391516747851
- Version / Model
- 40-3025G
- Catalog Number
- 40-3025G
- 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
- 3
- Public Version Date
- 2022-03-08
- Public Version Status
- Update
- Public Device Record Key
- dc2a3296-77a4-4469-b1b8-baa319c5cb7d
Device Description
Alkaline Phosphatase Conjugate, Anti-Human IgG (Goat), 4.5 mL
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- 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 |
|---|---|---|---|---|
| LLL | Extractable Antinuclear Antibody, Antigen And Control | Immunology | 866.5100 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 54826 | Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative screening for multiple types of antibodies to extractable nuclear antigens (anti-ENA) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05391516747851 | GS1 |
Customer Contacts
- Phone
- 800-325-3424
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius