FDA.reportPublic FDA data

CardioChek

Primary DI
00304040040539
Brand
CardioChek
Company
HENRY SCHEIN, INC.
Model
5700534
Catalog number
5700534
Device description
CardioChek Plus Analyzer Starter Pack
Published
2017-01-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true

Product Codes#

Code, Name table
CodeName
CGAGLUCOSE OXIDASE, GLUCOSE
CHHENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL
GIOTUBE, COLLECTION, CAPILLARY BLOOD
JGYCOLORIMETRIC METHOD, TRIGLYCERIDES
JJYMulti-analyte controls, all kinds (assayed)
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
GIOTube, Collection, Capillary BloodHematology1
JGYColorimetric Method, TriglyceridesClinical Chemistry1
JJYMulti-Analyte Controls, All Kinds (Assayed)Clinical Chemistry1
LBRLdl & Vldl Precipitation, HdlClinical Chemistry1
NBWSystem, Test, Blood Glucose, Over The CounterClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00304040040539PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00304040040539003040400405393040400405390304040040539

GMDN Terms#

Term, Definition table
TermDefinition
Multiple clinical chemistry enzyme IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of one or multiple clinical chemistry enzymes using an enzyme spectrophotometry method.

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 Temperature20 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature68 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
012430880
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10304040196974Henry Schein570586457058642026-05-14
10304040196981Henry Schein570586557058652026-05-14
10304040196998Henry Schein570586657058662026-05-14
10304040197001Henry Schein570586757058672026-05-14
10304040197018Henry Schein570586857058682026-05-14
10304040059446Henry Schein900445490044542019-02-13
10304040196790Henry Schein570584657058462026-04-21
10304040196806Henry Schein570584957058492026-04-21
10304040196660Henry Schein570583757058372026-04-17
10304040196677Henry Schein570583857058382026-04-17
10304040196684Henry Schein570583957058392026-04-17
10304040196691Henry Schein570584057058402026-04-17
10304040196707Henry Schein570584157058412026-04-17
10304040196714Henry Schein570584257058422026-04-17
10304040196653Henry Schein570583157058312026-04-10
00304040000236Henry Schein100-7773100-77732015-09-25
10304040119034Henry Schein570163357016332020-02-05
10304040119058Henry Schein570163457016342020-02-05
10304040119065Henry Schein570163657016362020-02-05
10304040119089Henry Schein570163857016382020-02-05

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