DEVICE: ChekMate™ Strips (00381930860019)
Device Identifier (DI) Information
ChekMate™ Strips
860
Not in Commercial Distribution
860
POLYMER TECHNOLOGY SYSTEMS, INC.
860
Not in Commercial Distribution
860
POLYMER TECHNOLOGY SYSTEMS, INC.
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.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
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? |
---|---|---|---|---|
52851 | 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.
|
Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
CHH | ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL |
CGA | GLUCOSE OXIDASE, GLUCOSE |
LBR | LDL & VLDL PRECIPITATION, HDL |
JGY | COLORIMETRIC METHOD, TRIGLYCERIDES |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K151530 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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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. |
Special Storage Condition, Specify: Keep away from sunlight. |
Storage Environment Humidity: between 20 and 80 Percent (%) Relative Humidity |
Storage Environment Temperature: between 68 and 80 Degrees Fahrenheit |
Storage Environment Temperature: between 20 and 27 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
a6e7d522-4721-4187-96e5-a5c878e0ba94
April 13, 2022
5
July 15, 2016
April 13, 2022
5
July 15, 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 |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
10381930860016
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(888)877-5610
customerservice@ptsdiagnostics.com
customerservice@ptsdiagnostics.com