DEVICE: PTS Panels® Triglycerides Test Strips (00381931716018)

Device Identifier (DI) Information

PTS Panels® Triglycerides Test Strips
1716
In Commercial Distribution
1716
POLYMER TECHNOLOGY SYSTEMS, INC.
00381931716018
GS1

25
835772872 *Terms of Use
PTS Panels® Triglycerides test strips are in vitro diagnostic devices used to monitor triglycerides levels in human whole blood. These test strips must be used in conjunction with a CardioChek® brand analyzer.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
Yes
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
66523 Triglyceride IVD, kit, rapid colorimetric, clinical
A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of triglycerides in a clinical specimen within a short period, relative to standard laboratory testing procedures, using a rapid colorimetric method. This is a rapid test commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
CDT LIPASE HYDROLYSIS/GLYCEROL KINASE ENZYME, TRIGLYCERIDES
JGY COLORIMETRIC METHOD, TRIGLYCERIDES
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 68 and 86 Degrees Fahrenheit
Storage Environment Temperature: between 20 and 30 Degrees Celsius
Special Storage Condition, Specify: Keep away from sunlight Keep dry
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

d3b9b6fa-7407-4843-b8fe-4d29b4b244ab
November 25, 2024
6
July 22, 2016
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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
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: 10381931716015 CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(877)870-5610
customerservice@ptsdiagnostics.com
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