DEVICE: PTS Panels eGLU™ Test Strips (00381932728010)
Device Identifier (DI) Information
PTS Panels eGLU™ Test Strips
2728
In Commercial Distribution
2728
POLYMER TECHNOLOGY SYSTEMS, INC.
2728
In Commercial Distribution
2728
POLYMER TECHNOLOGY SYSTEMS, INC.
PTS Panels eGLU™ test strips are in vitro diagnostic devices used to monitor glucose levels in human whole blood. These test strips must be used in conjunction with a CardioChek® Plus analyzer.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
Yes | |
No | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
52848 | Multiple lipid analyte IVD, kit, multiple technologies |
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of multiple lipid analytes [e.g., total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL)] to produce a lipid profile, using a number of different technologies on a single analyser. Some types may also detect additional analytes (e.g., glucose, ketones, uric acid).
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NBW | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER |
CGA | GLUCOSE OXIDASE, GLUCOSE |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K140068 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Keep away from sunlight. |
Special Storage Condition, Specify: Keep dry. |
Storage Environment Temperature: between 68 and 86 Degrees Fahrenheit |
Storage Environment Temperature: between 20 and 30 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
d038b49f-912d-48dc-ade9-3952646c8361
December 08, 2022
5
July 22, 2016
December 08, 2022
5
July 22, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
10381932728017
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(888)877-5610
customerservice@ptsdiagnostics.com
customerservice@ptsdiagnostics.com