Primary Device ID | 00381931716018 |
NIH Device Record Key | d3b9b6fa-7407-4843-b8fe-4d29b4b244ab |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | PTS Panels® Triglycerides Test Strips |
Version Model Number | 1716 |
Catalog Number | 1716 |
Company DUNS | 835772872 |
Company Name | POLYMER TECHNOLOGY SYSTEMS, INC. |
Device Count | 25 |
DM Exempt | false |
Pre-market Exempt | false |
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 | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | true |
Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight Keep dry |
Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight Keep dry |
Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight Keep dry |
Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight Keep dry |
Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight Keep dry |
Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight Keep dry |
Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight Keep dry |
Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight Keep dry |
Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight Keep dry |
Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight Keep dry |
Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight Keep dry |
Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight Keep dry |
Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight Keep dry |
Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight Keep dry |
Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight Keep dry |
Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight Keep dry |
Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight Keep dry |
Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight Keep dry |
Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight Keep dry |
Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight Keep dry |
Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight Keep dry |
Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight Keep dry |
Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight Keep dry |
Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight Keep dry |
Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight Keep dry |
Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight Keep dry |
Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight Keep dry |
Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight Keep dry |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00381931716018 [Primary] |
GS1 | 10381931716015 [Unit of Use] |
CDT | LIPASE HYDROLYSIS/GLYCEROL KINASE ENZYME, TRIGLYCERIDES |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-07-22 |
00381931789012 | PTS Panels® Triglycerides test strips are in vitro diagnostic devices used to monitor triglycer |
00381931716018 | PTS Panels® Triglycerides test strips are in vitro diagnostic devices used to monitor triglycer |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PTS PANELS 78640726 3179677 Live/Registered |
Polymer Technology Systems, Inc. 2005-05-31 |
PTS PANELS 78099027 not registered Dead/Abandoned |
Polymer Technology Systems, Inc. 2001-12-18 |