FDA UDI
In Commercial Distribution
🇺🇸 United States
Trinity Biotech
DI: 05391516749473
·
Model: Tri-stat 2 Analyzer
·
PRIMUS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Trinity Biotech
- Primary DI
- 05391516749473
- Version / Model
- Tri-stat 2 Analyzer
- Catalog Number
- 03-06-0002
- Company Name
- PRIMUS CORPORATION
- Labeler DUNS
- 790074793
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-08-14
- Public Version
- 1
- Public Version Date
- 2019-08-22
- Public Version Status
- New
- Public Device Record Key
- 36600990-266e-42f2-90ca-b04f372626fd
Device Description
Tri-stat 2 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 |
|---|---|---|---|---|
| LCP | Assay, Glycosylated Hemoglobin | Hematology | 864.7470 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35968 | Glycated haemoglobin (HbA1C) analyser IVD | A mains electricity (AC-powered) laboratory instrument intended to be used for the quantitative measurement of glycated haemoglobin (HbA1c), also known as glycohaemoglobin, glycosylated haemoglobin or glucosylated haemoglobin, in a clinical specimen. It typically uses a separation technique that is based on charge differences (i.e., ion-exchange chromatography, high pressure liquid chromatography, electrophoresis), chemical analysis (i.e., colorimetry, spectrophotometry), or structural differences (i.e., affinity chromatography and immunoassay). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05391516749473 | GS1 |
Customer Contacts
- Phone
- 800-325-3424
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K062658 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 28 Degrees Celsius