DEVICE: CardioChek® Plus Professional Analyzer (00381932700016)
Device Identifier (DI) Information
CardioChek® Plus Professional Analyzer
2700
In Commercial Distribution
2700
POLYMER TECHNOLOGY SYSTEMS, INC.
2700
In Commercial Distribution
2700
POLYMER TECHNOLOGY SYSTEMS, INC.
The CardioChek® Plus professional analyzer is intended for in vitro diagnostic use to test whole blood. The specific analyte measured is determined by the type of test strip chosen.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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62181 | Multiple clinical chemistry analyser IVD, point-of-care |
A portable, electrically-powered instrument intended to be used by health professionals at the point-of-care for the qualitative and/or quantitative in vitro detection of multiple clinical chemistry analytes in a clinical specimen, using one or more technology(ies) [e.g., microfluidics, electrometry, spectrophotometry, colorimetry, fluorimetry, radiometry, chemiluminescence]. Analytes detected may include electrolytes, specific proteins, clinical chemistry substrates (e.g., lipid profile), liver and/or cardiac function test analytes, and/or enzymes.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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LBR | LDL & VLDL PRECIPITATION, HDL |
CHH | ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL |
CGA | GLUCOSE OXIDASE, GLUCOSE |
NBW | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER |
JGY | COLORIMETRIC METHOD, TRIGLYCERIDES |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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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 10 and 40 Degrees Celsius |
Storage Environment Temperature: between 50 and 104 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
b90ea9c6-0a79-4ff7-ae2b-2fa94ef95bda
October 18, 2023
8
July 15, 2016
October 18, 2023
8
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 |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(888)877-5610
customerservice@ptsdiagnostics.com
customerservice@ptsdiagnostics.com