FDA.reportPublic FDA data

CardioChek

Primary DI
10304040037741
Brand
CardioChek
Company
HENRY SCHEIN, INC.
Model
5700414
Catalog number
5700414
Device description
CardioChek Lipid Panel Test
Published
2017-01-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
CHHENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL
JGYCOLORIMETRIC METHOD, TRIGLYCERIDES
LBRLDL & VLDL PRECIPITATION, HDL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CHHEnzymatic Esterase--Oxidase, CholesterolClinical Chemistry1
JGYColorimetric Method, TriglyceridesClinical Chemistry1
LBRLdl & Vldl Precipitation, HdlClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K022898000
K023558000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K022898000PTS PANELS LIPID PANEL TEST STRIPSPolymer Technology Systems, Inc.2002-09-24CHH
K023558000PTS PANELS LIPID PANEL TEST STRIPSPolymer Technology Systems, Inc.2002-11-15CHH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10304040037741PrimaryGS10
00304040037744Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1030404003774110304040037741
00304040037744003040400377443040400377440304040037744

GMDN Terms#

Term, Definition table
TermDefinition
Multiple lipid analyte IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of multiple lipid analytes [e.g., total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL)] to generate a lipid profile of a clinical specimen, using an enzyme spectrophotometry method. Some types may also detect additional analytes (e.g., glucose, ketones, uric acid).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight.
Special Storage Condition, Specify00Keep dry.
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
15
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10304040195038Criterion570581557058152026-07-29
10304040195045Criterion570581657058162026-07-29
10304040195052Criterion570581757058172026-07-29
10304040195069Criterion570581857058182026-07-29
10304040195076Criterion570582057058202026-07-29
10304040195083Criterion570581957058192026-07-29
10304040195090Criterion570582157058212026-07-29
10304040195106Criterion570582257058222026-07-29
00304040194416Henry Schein570572557057252026-07-20
00304040194423Henry Schein570572757057272026-07-20
00304040194430Henry Schein570572857057282026-07-20
00304040194447Henry Schein570572957057292026-07-20
00304040194348Henry Schein570569157056912025-12-15
00304040194355Henry Schein570569357056932025-12-15
00304040194362Henry Schein570569057056902025-12-15
00304040194386Henry Schein570570957057092025-12-15
10304040193362Henry Schein570560057056002026-06-25
10304040194048Essentials570567957056792026-06-25
10304040194055Essentials570567557056752026-06-25
10304040194062Essentials570567657056762026-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816042016080FORAFORA CARE INC.CHH2026-06-24
06935740725705Blood Lipid AnalyzerUrit Medical Electronic Co., Ltd.CHH2026-06-03
06935740725705Blood Lipid AnalyzerUrit Medical Electronic Co., Ltd.LBR2026-06-03
06935740725705Blood Lipid AnalyzerUrit Medical Electronic Co., Ltd.JGY2026-06-03
06935740725712Blood Lipid AnalyzerUrit Medical Electronic Co., Ltd.CHH2026-06-03
06935740725712Blood Lipid AnalyzerUrit Medical Electronic Co., Ltd.LBR2026-06-03
06935740725712Blood Lipid AnalyzerUrit Medical Electronic Co., Ltd.JGY2026-06-03
00816042016387FORAFORA CARE INC.CHH2026-04-27
00850014861834heartscare Total Cholesterol Test Strip (10pcs/box)Hearts Bio, Inc.CHH2026-04-17
00682607690053Mission Cholesterol Test Device - 3-in-1 Lipid Panel 25TAcon Laboratories, Inc.CHH2026-03-09
00682607690053Mission Cholesterol Test Device - 3-in-1 Lipid Panel 25TAcon Laboratories, Inc.LBR2026-03-09
00682607690053Mission Cholesterol Test Device - 3-in-1 Lipid Panel 25TAcon Laboratories, Inc.JGY2026-03-09
00682607690077Mission Cholesterol Optical Check DeviceAcon Laboratories, Inc.CHH2026-03-09
00682607690077Mission Cholesterol Optical Check DeviceAcon Laboratories, Inc.LBR2026-03-09
00682607690077Mission Cholesterol Optical Check DeviceAcon Laboratories, Inc.JGY2026-03-09
00682607690084Mission Cholesterol Control SolutionAcon Laboratories, Inc.CHH2026-03-09
00682607690084Mission Cholesterol Control SolutionAcon Laboratories, Inc.JGY2026-03-09
00682607690084Mission Cholesterol Control SolutionAcon Laboratories, Inc.LBR2026-03-09
00682607690091Mission Cholesterol Test Device - 3-in-1 Lipid Panel 5TAcon Laboratories, Inc.JGY2026-03-09
00682607690091Mission Cholesterol Test Device - 3-in-1 Lipid Panel 5TAcon Laboratories, Inc.LBR2026-03-09
00682607690091Mission Cholesterol Test Device - 3-in-1 Lipid Panel 5TAcon Laboratories, Inc.CHH2026-03-09
10682607690050Mission Cholesterol Test Device - 3-in-1 Lipid Panel 25TAcon Laboratories, Inc.LBR2026-03-09
00682607690060Mission Cholesterol MeterAcon Laboratories, Inc.JGY2026-03-09
00682607690060Mission Cholesterol MeterAcon Laboratories, Inc.LBR2026-03-09
00682607690060Mission Cholesterol MeterAcon Laboratories, Inc.CHH2026-03-09
10682607690074Mission Cholesterol Optical Check DeviceAcon Laboratories, Inc.JGY2026-03-09
10682607690081Mission Cholesterol Control SolutionAcon Laboratories, Inc.LBR2026-03-09
10682607690098Mission Cholesterol Test Device - 3-in-1 Lipid Panel 5TAcon Laboratories, Inc.CHH2026-03-09
04710469879548XPER Technology Multi-Functional Monitoring System Procheck SmartTAIDOC TECHNOLOGY CORPORATIONCHH2025-10-30
04710469879555XPER Technology Multi-Functional Monitoring System Procheck WittyTAIDOC TECHNOLOGY CORPORATIONCHH2025-10-30