Blood Uric Acid Test Strips
- Primary DI
- 16971404130949
- Brand
- Blood Uric Acid Test Strips
- Company
- e-Linkcare Meditech Co., Ltd
- Model
- SM411
- Device description
- Blood uric acid Monitoring Meter with Blood Uric Acid Test Strips are intended for use for the quantitative measurement of uric acid in fresh capillary whole blood or venous whole blood
- Published
- 2021-12-17
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- OTC
- true
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| LFQ | Acid, Uric, Acid Reduction Of Ferric Ion |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| LFQ | Acid, Uric, Acid Reduction Of Ferric Ion | Clinical Chemistry | 1 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 26971404130946 | Package | GS1 | 25 | In Commercial Distribution |
| 26971404131202 | Package | GS1 | 50 | In Commercial Distribution |
| 36971404130035 | Package | GS1 | 100 | In Commercial Distribution |
| 36971404130042 | Package | GS1 | 160 | In Commercial Distribution |
| 36971404130943 | Package | GS1 | 100 | Not in Commercial Distribution |
| 36971404131209 | Package | GS1 | 160 | Not in Commercial Distribution |
| 16971404130949 | Primary | GS1 | 0 | |
| 06971404130942 | Unit of Use | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 26971404130946 | 26971404130946 | |
| 26971404131202 | 26971404131202 | |
| 36971404130035 | 36971404130035 | |
| 36971404130042 | 36971404130042 | |
| 36971404130943 | 36971404130943 | |
| 36971404131209 | 36971404131209 | |
| 16971404130949 | 16971404130949 | |
| 06971404130942 | 06971404130942 | 6971404130942 |
GMDN Terms#
| Term | Definition |
|---|---|
| Uric acid 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 quantitative measurement of uric acid in a clinical specimen. |
Regulatory Flags#
- DUNS number
- 540481217
- Device count
- 25
- Premarket exempt
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 06971404130911 | Blood Ketone Monitoring System | PM900B | 2021-12-17 | |
| 06971404131581 | Blood Ketone Control solution(level 1) | CM211 | 2022-05-17 | |
| 06971404131598 | Blood Ketone Control solution(level 2) | CM211 | 2022-05-17 | |
| 06971404131604 | Blood Ketone Control solution(level 3) | CM211 | 2022-05-17 | |
| 06971404131611 | Uric Acid Control solution(level 1) | CM311 | 2022-05-17 | |
| 06971404131628 | Uric Acid Control solution(level 2) | CM311 | 2022-05-17 | |
| 06971404130928 | Blood Uric Acid Monitoring System | PM900C | 2021-12-17 | |
| 16971404131199 | Blood Ketone Test Strips | SM311 | 2021-12-17 | |
| 16971404130918 | Blood Ketone Monitoring System | PM900B | 2021-12-17 | |
| 16971404130925 | Blood Uric Acid Monitoring System | PM900C | 2021-12-17 | |
| 26971404130946 | Blood Uric Acid Test Strips | SM411 | 2021-12-17 | |
| 26971404131196 | Blood Ketone Test Strips | SM311 | 2021-12-17 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 00816042014475 | FORA | FORA CARE INC. | LFQ | 2023-10-31 |
| 00850014861353 | HeartsCare C1 URIC ACID TEST STRIPS(10PCS/BOX) | Hearts Bio, Inc. | LFQ | 2023-08-08 |
| 00816042014116 | FORA | FORA CARE INC. | LFQ | 2023-06-26 |
| 00816042014192 | FORA | FORA CARE INC. | LFQ | 2023-06-26 |
| 00816042014109 | FORA | FORA CARE INC. | LFQ | 2023-06-26 |
| 80816042014112 | FORA | FORA CARE INC. | LFQ | 2023-06-26 |
| 00816042014185 | FORA | FORA CARE INC. | LFQ | 2023-06-26 |
| 80816042014198 | FORA | FORA CARE INC. | LFQ | 2023-06-26 |
| 06971404131611 | Uric Acid Control solution(level 1) | e-Linkcare Meditech Co., Ltd | LFQ | 2022-05-17 |
| 06971404131628 | Uric Acid Control solution(level 2) | e-Linkcare Meditech Co., Ltd | LFQ | 2022-05-17 |
| 00886338000031 | UASure II Blood Uric Acid Monitoring System | APEX BIOTECHNOLOGY CORP. | LFQ | 2021-12-27 |
| 00886338000062 | UASure II Blood Uric Acid Test Strips 25s | APEX BIOTECHNOLOGY CORP. | LFQ | 2021-12-27 |
| 06971404130928 | Blood Uric Acid Monitoring System | e-Linkcare Meditech Co., Ltd | LFQ | 2021-12-17 |
| 16971404130925 | Blood Uric Acid Monitoring System | e-Linkcare Meditech Co., Ltd | LFQ | 2021-12-17 |
| 26971404130946 | Blood Uric Acid Test Strips | e-Linkcare Meditech Co., Ltd | LFQ | 2021-12-17 |
| 04713648766462 | UASure Blood Uric Acid Monitoring Meter | APEX BIOTECHNOLOGY CORP. | LFQ | 2020-05-11 |
| 04713648766479 | UASure Blood Uric Acid Test Strip | APEX BIOTECHNOLOGY CORP. | LFQ | 2020-05-11 |