| Primary Device ID | 10381934774012 |
| NIH Device Record Key | 753b28d5-2467-48af-848a-2973d4d2ed54 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PTS Diagnostics Capillary Tubes |
| Version Model Number | REF 4774 |
| Catalog Number | 4774 |
| Company DUNS | 835772872 |
| Company Name | POLYMER TECHNOLOGY SYSTEMS, INC. |
| Device Count | 25 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Phone | +1(877)870-5610 |
| customerservice@ptsdiagnostics.com | |
| Phone | +1(877)870-5610 |
| customerservice@ptsdiagnostics.com | |
| Phone | +1(877)870-5610 |
| customerservice@ptsdiagnostics.com | |
| Phone | +1(877)870-5610 |
| customerservice@ptsdiagnostics.com | |
| Phone | +1(877)870-5610 |
| customerservice@ptsdiagnostics.com | |
| Phone | +1(877)870-5610 |
| customerservice@ptsdiagnostics.com | |
| Phone | +1(877)870-5610 |
| customerservice@ptsdiagnostics.com |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00381934774015 [Primary] |
| GS1 | 10381934774012 [Unit of Use] |
| GIO | TUBE, COLLECTION, CAPILLARY BLOOD |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-06-24 |
| Device Publish Date | 2025-06-16 |
| 10381934770014 - Cholesterol | 2025-06-24 PTS Panels® cholesterol self-test strips are for the quantitative measurement of total cholesterol in capillary whole blood fro |
| 10381934774012 - PTS Diagnostics Capillary Tubes | 2025-06-24PTS Collect Capillary Tubes are intended to obtain a drop of whole blood from a fingerstick for self-testing. Capillary tubes are single-use only. Do not reuse. |
| 10381934774012 - PTS Diagnostics Capillary Tubes | 2025-06-24 PTS Collect Capillary Tubes are intended to obtain a drop of whole blood from a fingerstick for self-testing. Capillary tubes ar |
| 10381933080015 - A1CNow Self Check, 8ct. | 2023-11-02 The A1CNOW® Self Check Test System provides quantitative measurement of the percent of glycated hemoglobin (%HbA1C or %A1C) lev |
| 10021292015029 - TRUE+ A1CNow Self Check | 2023-08-07 The A1CNOW® Self Check Test System provides quantitative measurement of the percent of glycated hemoglobin (%HbA1C or %A1C) lev |
| 10381932488010 - Assy Vial, eGLU, 13 ct. | 2023-08-07 The CardioChek Plus Home eGLU™ glucose test strips are in vitro diagnostic devices used to measure glucose levels in human who |
| 10381934753017 - Lipid Panel, 15ct., CCPlus Home | 2023-06-28 CardioChek® Plus Home Lipid Panel Self-Test test strips are in vitro diagnostic devices used to measure total cholesterol, HDL |
| 10381934755011 - eGLU, 15ct., CCPlus Home | 2023-06-28 The CardioChek Plus Home eGLU™ glucose test strips are in vitro diagnostic devices used to measure glucose levels in human who |
| 10381934752010 - Lipid + eGLU Smart Bundle™ , CC Plus Home (15-pk) | 2023-06-09 CardioChek Plus Lipid + eGLU Smart Bundle™ Self-Test test strips are in vitro diagnostic devices used to measure total cholest |