FDA UDI
In Commercial Distribution
🇺🇸 United States
ThromboTek PSe
DI: 00859394006095
·
Model: 90-480
·
R 2 DIAGNOSTICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ThromboTek PSe
- Primary DI
- 00859394006095
- Version / Model
- 90-480
- Catalog Number
- 90-480
- Company Name
- R 2 DIAGNOSTICS, INC.
- Labeler DUNS
- 956610125
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-11-15
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- b6240e4b-d734-4b7c-9ab1-09cc86699fcb
Device Description
Protein S Kit 80-160 DET
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
- 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 |
|---|---|---|---|---|
| GGP | Test, Qualitative And Quantitative Factor Deficiency | Hematology | 864.7290 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56208 | Protein S IVD, kit, clotting | A collection of reagents and other associated materials intended to be used for the quantitative measurement of protein S in a clinical specimen, using a clotting method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00859394006095 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K082631 | 000 |