Assure PT Care Test Strip Kit
- Primary DI
- 00850040656039
- Brand
- Assure PT Care Test Strip Kit
- Company
- COAGUSENSE INC.
- Model
- 350218
- Catalog number
- 350218
- Device description
- Arkray Assure PT Care Test Strip, 50 Count
- Published
- 2023-04-06
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| GJS | Test, Time, Prothrombin |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| GJS | Test, Time, Prothrombin | Hematology | 2 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 10850040656036 | Package | GS1 | 12 | In Commercial Distribution |
| 00850040656039 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 10850040656036 | 10850040656036 | ||
| 00850040656039 | 00850040656039 | 850040656039 | 0850040656039 |
GMDN Terms#
| Term | Definition |
|---|---|
| Prothrombin time (PT) IVD, kit, rapid clotting, clinical | A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative determination of the prothrombin time (PT) of a clinical specimen, with or without standardization to the international normalized ratio (INR), within a short period relative to standard laboratory testing procedures using a clotting method. This is a rapid test commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing. |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 007943352
- Device count
- 1
- Kit
- true
- Lot or batch
- true
- Expiration date on label
- true
- No natural rubber latex
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00860007370809 | Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing | 300550 | 300550 | 2026-05-12 |
| 00850040656022 | Assure PT Care PT/INR Monitoring System | 350222 | 350222 | 2023-04-06 |
| 00860007370861 | Coag-sense | 03F73-03 | 06F73-03 | 2021-09-30 |
| 00860007370878 | Coag-sense | 03F73-05 | 06F73-05 | 2021-09-30 |
| 00861900000398 | Coag-Sense Test Strip Kit, 50 ct. | 100218 | 03P56-50 | 2021-09-09 |
| 00861900000350 | Coag-Sense PT/INR Meter | 200107 | 03P73-01 | 2019-04-03 |
| 00861900000374 | Coag-Sense PT/INR Professional System | 200222 | 03P70-02 | 2019-04-03 |
| 00861900000381 | Coag-Sense PT/INR Patient Self-Test System | 200221 | 03P70-01 | 2019-04-03 |
| 00861900000305 | Coag-Sense | 100107 | 03P63-01 | 2018-09-23 |
| 00861900000312 | Coag-sense | 100222 | 03P60-01 | 2018-09-23 |
| 00861900000329 | Coag-sense | 100221 | 03P50-01 | 2018-09-23 |
| 00861900000336 | Coag-sense | 100218 | 03P56-50 | 2018-09-23 |
| 00861900000343 | Coag-sense | 100250 | 03P69-10 | 2018-09-23 |
| 10861900000395 | Coag-Sense Test Strip Kit, 50 ct. | 100218 | 03P56-50 | 2021-09-09 |
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| 09360136000086 | Xprecia Prime™ Coagulation Analyzer | UNIVERSAL BIOSENSORS PTY LTD | GJS | 2024-08-27 |
| 09360136000093 | Xprecia Prime™ PT/INR Test Strips | UNIVERSAL BIOSENSORS PTY LTD | GJS | 2024-08-27 |
| 08436540291134 | microINR ® Link Kit | ILINE MICROSYSTEMS SL | GJS | 2024-08-02 |
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| 00850053916205 | IDG/Sanzay | IDG/SANZAY Corporation | GJS | 2024-07-03 |
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| 00630414639871 | Dade Innovin | Siemens Healthcare Diagnostics Products GmbH | GJS | 2024-03-25 |
| 00630414639888 | Dade Innovin | Siemens Healthcare Diagnostics Products GmbH | GJS | 2024-03-25 |
| 00630414639963 | Thromborel S | Siemens Healthcare Diagnostics Products GmbH | GJS | 2024-03-25 |
| 00630414640006 | Dade Innovin | Siemens Healthcare Diagnostics Products GmbH | GJS | 2024-03-25 |
| 00842768019593 | Dade Innovin | Siemens Healthcare Diagnostics Products GmbH | GJS | 2024-03-25 |
| 00842768019609 | Dade Innovin | Siemens Healthcare Diagnostics Products GmbH | GJS | 2024-03-25 |
| 00842768018749 | Thromborel S | Siemens Healthcare Diagnostics Products GmbH | GJS | 2024-03-25 |
| 00842768019586 | Dade Innovin | Siemens Healthcare Diagnostics Products GmbH | GJS | 2024-03-25 |
| 00850053916182 | IDG/Sanzay | IDG/SANZAY Corporation | GJS | 2024-01-12 |
| 00054749004782 | i-STAT PTplus Cartridge | Abbott Point of Care Inc. | GJS | 2024-01-10 |
| 00054749004843 | i-STAT PTplus Control Level 1 | Abbott Point of Care Inc. | GJS | 2024-01-10 |
| 00054749004850 | i-STAT PTplus Control Level2 | Abbott Point of Care Inc. | GJS | 2024-01-10 |
| 00365702702356 | CoaguChek Vantus | Roche Diagnostics GmbH | GJS | 2023-12-01 |
| 00850040656022 | Assure PT Care PT/INR Monitoring System | COAGUSENSE INC. | GJS | 2023-04-06 |
| 00860007370861 | Coag-sense | COAGUSENSE INC. | GJS | 2021-09-30 |
| 00860007370878 | Coag-sense | COAGUSENSE INC. | GJS | 2021-09-30 |
| 00861900000398 | Coag-Sense Test Strip Kit, 50 ct. | COAGUSENSE INC. | GJS | 2021-09-09 |
| 10861900000395 | Coag-Sense Test Strip Kit, 50 ct. | COAGUSENSE INC. | GJS | 2021-09-09 |
| 08436540290717 | microINR ® CHIPS | ILINE MICROSYSTEMS SL | GJS | 2021-05-28 |
| 08436540290816 | microINR ® Meter | ILINE MICROSYSTEMS SL | GJS | 2021-05-28 |
| 08436540290700 | microINR ® CHIPS | ILINE MICROSYSTEMS SL | GJS | 2021-05-28 |
| 08436540290694 | microINR ® Meter | ILINE MICROSYSTEMS SL | GJS | 2021-05-28 |