FDA UDI
In Commercial Distribution
🇺🇸 United States
microINR ® Link Kit
DI: 08436540291134
·
Model: KTL0001AD
·
ILINE MICROSYSTEMS SL
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- microINR ® Link Kit
- Primary DI
- 08436540291134
- Version / Model
- KTL0001AD
- Company Name
- ILINE MICROSYSTEMS SL
- Labeler DUNS
- 460067955
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-02
- Public Version
- 2
- Public Version Date
- 2026-03-25
- Public Version Status
- Update
- Public Device Record Key
- e065d93a-5b99-49a3-bdb3-6cefd2183bcb
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 |
|---|---|---|---|---|---|---|
| Direct Marking | 08436540290915 | GS1 | ||||
| Primary | 08436540291134 | GS1 |