CardioChek Plus Home Lipid Panel Self-Test Strip 2ct
Catalogue number 4722, listed by Polymer Technology Systems, United States, under Ldl & Vldl Precipitation, Hdl. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
Who Else Makes It
Concentrated in Zhejiang (2), Guangxi (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Acon Biotech (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 29 |
| Urit Medical Electronic Co., Ltd. | Guilin | Guangxi | Contract manufacturer | 28 |
| Hangzhou Lysun Biotechnology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 22 |
Record
| Listed by | Polymer Technology Systems, United States |
|---|---|
| FDA product code | LBR |
| Device type | Ldl & Vldl Precipitation, Hdl |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1475 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K151545 |
| Record published | 2021-02-08 |
| Record revised | 2023-07-06 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep away from sunlight.; Special storage condition: Keep dry.; Storage environment temperature 20 to 30 °C; Storage environment temperature 68 to 86 °F |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 4722 | 2 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pointe Scientific, Inc. | Horiba Instruments Incorporated | 11 |
| Synermed® | Infrared Laboratory Systems LLC | 4 |
| LDL-Cholesterol Gen.3 | Roche Diagnostics Gmbh | 3 |
| L-Type HDL-C Reagent 2 | Fujifilm Wako Pure Chemical Corporation | 2 |
| Teco Diagnostics Direct HDL Cholesterol Reagent Kit TC-Matrix | Teco Diagnostics | 2 |
| N-geneous LDL Cholesterol Reagent (R1) | Sekisui Diagnostics, LLC | 2 |
| N-geneous LDL Cholesterol Reagent (R2) | Sekisui Diagnostics, LLC | 2 |
| PTS Panels® HDL Cholesterol Test Strips | Polymer Technology Systems | 2 |
| Teco Diagnostics HDL Cholesterol Reagent Set | Teco Diagnostics | 2 |
| CardioChek | Henry Schein, Inc. | 2 |
| L-Type HDL-C Reagent 1 | Fujifilm Wako Pure Chemical Corporation | 2 |
| Carolina Liquid Chemistries Corp.® CLC720 HDL RGT KIT Product No. ST616 | Carolina Liquid Chemistries | 1 |
Showing 12 of 47. All products under Ldl & Vldl Precipitation, Hdl
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K990247 | 1999-05-28 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Polymer Technology Systems | 510(k) number | 2019-06-07 | Class III | Under Investigation by firm | The MEMo chips provided with lot P901 may be mislabeled, the MEMo Chip may display Q901 on the analyzer LCD screen, instead of P901 | 1,887 vials US; 2,728 vials OUS | 2020-07-08 |
| Polymer Technology Systems | 510(k) number | 2019-06-07 | Class III | Under Investigation by firm | The MEMo chips provided with lot P901 may be mislabeled, the MEMo Chip may display Q901 on the analyzer LCD screen, instead of P901 | 559 vials | 2020-07-08 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.