FDA UDI
In Commercial Distribution
🇺🇸 United States
Trinity Biotech
DI: 05391516744102
·
Model: Ultra2 Genesys Variants Analyzer
·
PRIMUS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Trinity Biotech
- Primary DI
- 05391516744102
- Version / Model
- Ultra2 Genesys Variants Analyzer
- Catalog Number
- 03-01-0045
- Company Name
- PRIMUS CORPORATION
- Labeler DUNS
- 790074793
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-20
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 9629d085-db45-4516-883c-e1d2eeb8ded3
Device Description
Hemoglobin variants assay, Ultra2 Genesys Variants Analyzer
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GKA | Abnormal Hemoglobin Quantitation | Hematology | 864.7415 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61759 | Inherited haemoglobinopathy IVD, kit, liquid chromatography | A collection of reagents and other associated materials intended to be used to evaluate a clinical specimen to diagnose, monitor or predict inherited haemoglobinopathies or haemoglobin variants, which may be associated with HbC (haemoglobin C), HbE, HbS (sickle-cell disease), Hb Lepore, Hb constant spring, alpha-thalassaemia and/or beta-thalassaemia, using a liquid chromatography method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05391516744102 | GS1 |
Customer Contacts
- Phone
- 800-325-3424
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K955283 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 40 Degrees Celsius