FDA.reportPublic FDA data

CardioChek® Plus Professional Analyzer, Refurbished

Primary DI
00381932702010
Brand
CardioChek® Plus Professional Analyzer, Refurbished
Company
POLYMER TECHNOLOGY SYSTEMS, INC.
Model
2702
Catalog number
2702
Device description
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.
Published
2016-07-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CGAGLUCOSE OXIDASE, GLUCOSE
CHHENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL
JGYCOLORIMETRIC METHOD, TRIGLYCERIDES
LBRLDL & VLDL PRECIPITATION, HDL
NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CGAGlucose Oxidase, GlucoseClinical Chemistry2
CHHEnzymatic Esterase--Oxidase, CholesterolClinical Chemistry1
JGYColorimetric Method, TriglyceridesClinical Chemistry1
LBRLdl & Vldl Precipitation, HdlClinical Chemistry1
NBWSystem, Test, Blood Glucose, Over The CounterClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140068000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140068000CARDIOCHEK PLUS TEST SYSTEM, CARDIOCHEK HOME TEST SYSTEMPolymer Technology Systems, Inc.2015-05-22NBW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00381932702010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00381932702010003819327020103819327020100381932702010

GMDN Terms#

Term, Definition table
TermDefinition
Multichannel clinical chemistry analyser IVD, point-of-care, battery-poweredA portable, battery-powered instrument intended to be used by health professionals at the point-of-care to analyse a clinical specimen for the qualitative and/or quantitative determination of multiple clinical chemistry analytes simultaneously from multiple analytical processes. Analytes measured may include electrolytes, specific proteins, lipids, and kidney, liver and/or cardiac function test analytes using two or more technologies which may include microfluidics, electrometry, spectrophotometry, fluorimetry, radiometry and/or chemiluminescence.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight.
Special Storage Condition, Specify00Keep dry.
Storage Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Temperature50 Degrees Fahrenheit104 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)870-5610customerservice@ptsdiagnostics.com
+1(888)877-5610customerservice@ptsdiagnostics.com

Regulatory Flags#

DUNS number
835772872
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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10381934770014CholesterolREF 477047702025-06-16
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00381932488013Assy Vial, eGLU, 13 ct.REF 2488REF 24882023-07-30
10021292015029TRUE+ A1CNow Self CheckC8H01-02C8H01-022023-07-30
10381932488010Assy Vial, eGLU, 13 ct.REF 2488REF 24882023-07-30

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