FDA.reportPublic FDA data

CardioChek® Analyzer; Refurbished

Primary DI
00381931782013
Brand
CardioChek® Analyzer; Refurbished
Company
POLYMER TECHNOLOGY SYSTEMS, INC.
Model
1782
Catalog number
1782
Device description
The CardioChek® 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
NAQLIPOPROTEIN, HIGH DENSITY, HDL, OVER THE COUNTER
NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
NGOTEST, TRIGLYCERIDES, 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
NAQLipoprotein, High Density, Hdl, Over The CounterClinical Chemistry1
NBWSystem, Test, Blood Glucose, Over The CounterClinical Chemistry2
NGOTest, Triglycerides, Over The CounterClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K014099000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K014099000BIOSCANNER PLUSPolymer Technology Systems, Inc.2001-12-21NBW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00381931782013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00381931782013003819317820133819317820130381931782013

GMDN Terms#

Term, Definition table
TermDefinition
Multichannel clinical chemistry analyser IVD, home-use, battery-poweredA portable, battery-powered instrument intended to be used by a layperson in the home or similar environment 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 Keep dry
Special Storage Condition, Specify00Keep away from sunlight.
Special Storage Condition, Specify00Keep away from sunlightKeep dry
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(877)870-5610customerservice@ptsdiagnostics.com

Regulatory Flags#

DUNS number
835772872
Device count
1
Serial number
true

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00381932488013Assy Vial, eGLU, 13 ct.REF 2488REF 24882023-07-30
10021292015029TRUE+ A1CNow Self CheckC8H01-02C8H01-022023-07-30
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