FDA UDI
In Commercial Distribution
🇺🇸 United States
Trinity Biotech
DI: 05391516743228
·
Model: R1129
·
TRINITY BIOTECH PUBLIC LIMITED COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Trinity Biotech
- Primary DI
- 05391516743228
- Version / Model
- R1129
- Catalog Number
- R1129
- Company Name
- TRINITY BIOTECH PUBLIC LIMITED COMPANY
- Labeler DUNS
- 988298840
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 83df26f5-d7cd-477c-9ef1-ee2f7a0793ae
Device Description
Red Cell Lysing Reagent (4 x 25mL)
Device Characteristics
- Single Use
- No
- 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
- 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 |
|---|---|---|---|---|
| JBL | Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Quantitative | Hematology | 864.7360 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55937 | Red cell glucose-6-phosphate dehydrogenase (G6PD) 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 determination of glucose-6-phosphate dehydrogenase (G6PD) enzyme activity of red cells from a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05391516743228 | GS1 |
Customer Contacts
- Phone
- +35312769800
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K790211 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 4 x 25 mL |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius