DEVICE: ChekMate™ Strips (00381930860019)

Device Identifier (DI) Information

ChekMate™ Strips
860
In Commercial Distribution
860
POLYMER TECHNOLOGY SYSTEMS, INC.
00381930860019
GS1

2
835772872 *Terms of Use
ChekMate™ Strips are dry strips that mimic the use of the PTS Panels test strips to check the CardioChek analyzer system optics, calibration, and result handling algorithms.
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Device Characteristics

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

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Glucose/ketone/lipid profile IVD, calibrator A material which is used to establish known points of reference for a number of assays intended to be used together to produce a profile consisting of one or multiple clinical chemistry analytes which may include glucose, ketones and/or a lipid profile.
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FDA Product Code

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Product Code Product Code Name
CHH ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL
CGA GLUCOSE OXIDASE, GLUCOSE
LBR LDL & VLDL PRECIPITATION, HDL
JGY COLORIMETRIC METHOD, TRIGLYCERIDES
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K151530 000
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Sterilization

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

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Storage and Handling
Special Storage Condition, Specify: The strips should always be stored in the original container when not in use to protect from light and from accidental scratching.
Special Storage Condition, Specify: Do not expose strips to high humidity, extreme heat, cold, dust or dirt.
Special Storage Condition, Specify: Keep dry.
Storage Environment Temperature: between 68 and 80 Degrees Fahrenheit
Storage Environment Temperature: between 20 and 27 Degrees Celsius
Special Storage Condition, Specify: Keep away from sunlight.
Storage Environment Humidity: between 20 and 80 Percent (%) Relative Humidity
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

a6e7d522-4721-4187-96e5-a5c878e0ba94
July 06, 2018
3
July 15, 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: 10381930860016 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(888)870-5610
customerservice@ptsdiagnostics.com
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