FDA.reportPublic FDA data

Chemcard Cholesterol

Primary DI
00737051548303
Brand
Chemcard Cholesterol
Company
CHEMATICS, INC.
Model
43001
Device description
The CHEMCARD™ Cholesterol Test provides a preliminarysemi-quantitative analytical test result that can be used to identify elevated blood cholesterollevels associated with increased risk of coronary artery disease.510K Cleared for Professional Use Only.
Published
2016-09-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CHHEnzymatic Esterase--Oxidase, Cholesterol

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CHHEnzymatic Esterase--Oxidase, CholesterolClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K864159000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K864159000SOLID PHASE DETER SERUM CHOLESTEROL FR WHOLE BLOODChem-Elec, Inc.1988-06-10CHH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00737051548310PackageGS124In Commercial Distribution
00737051548327PackageGS112In Commercial Distribution
00737051548303PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00737051548310007370515483107370515483100737051548310
00737051548327007370515483277370515483270737051548327
00737051548303007370515483037370515483030737051548303

GMDN Terms#

Term, Definition table
TermDefinition
Multiple lipid analyte IVD, kit, colorimetric, rapid, professional/self-testA collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative screening of multiple lipid analytes [e.g., total cholesterol, high-density lipoprotein (HDL) and low density lipoprotein (LDL)] to generate a lipid profile, within a short period of time relative to standard laboratory testing procedures, using a colorimetric method. This test is commonly used in the laboratory or in point-of-care analyses to screen patients at risk of developing coronary artery disease and/or lipid metabolism disorders. It is also available [non-prescription] over-the-counter (OTC) for self-testing by a layperson in the home or similar environment.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Fahrenheit86 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
1-800-348-5174info@chematics.com

Regulatory Flags#

DUNS number
196929947
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00737051654806Alco-Screen550012016-09-29
00737051863109Alco-Screen02560012016-09-29
00737051736908Chemcard Glucose470002016-09-29
00737051548327Chemcard Cholesterol430012016-09-29
00737051736922Chemcard Glucose470002016-09-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06935740725705Blood Lipid AnalyzerUrit Medical Electronic Co., Ltd.CHH2026-06-03
06935740725712Blood Lipid AnalyzerUrit Medical Electronic Co., Ltd.CHH2026-06-03
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
00682607690077Mission Cholesterol Optical Check DeviceAcon Laboratories, Inc.CHH2026-03-09
00682607690084Mission Cholesterol Control SolutionAcon Laboratories, Inc.CHH2026-03-09
00682607690091Mission Cholesterol Test Device - 3-in-1 Lipid Panel 5TAcon Laboratories, Inc.CHH2026-03-09
00682607690060Mission Cholesterol MeterAcon Laboratories, Inc.CHH2026-03-09
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
04719893233834XPER Technology Procheck Witty Procheck Smart Total Cholesterol Test StripsTAIDOC TECHNOLOGY CORPORATIONCHH2025-10-30
00850014861575HeartsCare C1 Plus Multi-Functional Monitoring SystemHearts Bio, Inc.CHH2025-07-02
00381934770017CholesterolPOLYMER TECHNOLOGY SYSTEMS, INC.CHH2025-06-16
10381934770014CholesterolPOLYMER TECHNOLOGY SYSTEMS, INC.CHH2025-06-16
00380740158125AlinityABBOTT IRELANDCHH2025-04-15
00380740158132ARCHITECTABBOTT IRELANDCHH2025-04-15
00380740158149ARCHITECTABBOTT IRELANDCHH2025-04-15
00850014861056HeartsCare C1 Plus Multi-Functional Monitoring SystemHearts Bio, Inc.CHH2025-03-31
00816042015205FORAFORA CARE INC.CHH2025-03-14
80816042015201FORAFORA CARE INC.CHH2025-03-14
06935740726986Blood Lipid Test StripUrit Medical Electronic Co., Ltd.CHH2024-07-12
08806141303701Newfoundland Cholesterol TestDFI CO.,LTDCHH2024-05-29
00850053916083IDG/SanzayIDG/SANZAY CorporationCHH2024-01-09
00893038002883Cholestech LDX™Alere San Diego, Inc.CHH2023-12-20
00893038002890Cholestech LDX™Alere San Diego, Inc.CHH2023-12-20
00893038002906Cholestech LDX™Alere San Diego, Inc.CHH2023-12-20
00893038002913Cholestech LDX™Alere San Diego, Inc.CHH2023-12-20
00893038002920Cholestech LDX™Alere San Diego, Inc.CHH2023-12-20