FDA UDI
Not in Commercial Distribution
🇺🇸 United States
microINR ® Link Kit
DI: 08436540290908
·
Model: KTE0001AD
·
ILINE MICROSYSTEMS SL
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- microINR ® Link Kit
- Primary DI
- 08436540290908
- Version / Model
- KTE0001AD
- Company Name
- ILINE MICROSYSTEMS SL
- Labeler DUNS
- 460067955
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-04-01
- Public Version
- 2
- Public Version Date
- 2024-08-08
- Public Version Status
- Update
- Public Device Record Key
- c9fd33bf-149d-4304-b637-f8c21ed9fdd7
- Distribution End Date
- 2024-08-02
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
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| GJS | Test, Time, Prothrombin | Hematology | 864.7750 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62541 | Coagulation analyser IVD, home-use, battery-powered | An exclusively battery-powered instrument intended to be used for the qualitative and/or quantitative in vitro determination of one or multiple coagulation components involved in haemostasis in a clinical specimen [e.g., performs tests such as whole blood prothrombin time (WBPT), whole blood partial thromboplastin time (WBPTT), heparin dose response, activated clotting time (ACT)]; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. It may incorporate spectrophotometry, turbidimetry, nephelometry, electrometry and/or mechanical means of clot formation or end point detection. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08436540290908 | GS1 | ||||
| Direct Marking | 08436540290915 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K231711 | 000 |