FDA.reportPublic FDA data

ClearChem Diagnostics Inc. Cholesterol, Total

Primary DI
00852169008157
Brand
ClearChem Diagnostics Inc. Cholesterol, Total
Company
CLEARCHEM DIAGNOSTICS INC.
Model
CHL1100
Catalog number
CHL1100
Device description
In Vitro Diagnostics testing kit R1:4X60mL
Published
2018-04-30
Public version status
New
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852169008157PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852169008157008521690081578521690081570852169008157

GMDN Terms#

Term, Definition table
TermDefinition
Total cholesterol lipid IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of total cholesterol lipid in a clinical specimen.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume240Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Refrigerated
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(714)734-8041dwheat@clearchem.net

Regulatory Flags#

DUNS number
010655581
Device count
1
DM exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852169008041ClearChem Diagnostics Inc. AmylaseAMY1030AMY10302018-04-30
00852169008010ClearChem Diagnostics Inc. AlbuminALB1000ALB10002018-04-30
00852169008317ClearChem Diagnostics Inc. Total BilirubinBRB2122023-01-20
00852169008324ClearChem Diagnostics Inc. Direct BilirubinBRD2102023-01-20
00852169008379ClearChem Diagnostics Inc. Vitamin D (25-OH-D) KitVTD11002023-01-20
00852169008386ClearChem Diagnostics Inc. Vitamin D (25-OH-D) SetVTD12002023-01-20
00852169008126ClearChem Diagnostics Inc. Creatinine (Jaffe)CRE1120CRE11202018-04-30
00852169008171ClearChem Diagnostics Inc. High Sensitivity C-Reactive Protein (hS-CRP)CRP1320CRP13202018-04-30
00852169008201ClearChem Diagnostics Inc. Low-Density Lipoprotein (LDL) CholesterolLDL1230LDL12302018-05-18
00852169008294ClearChem Diagnostics Inc. MicroProtein, TotalMPN2020MPN20202018-06-08
00852169008232ClearChem Diagnostics Inc. TIBC-DirectITI1160ITI11602018-05-22
00852169008270ClearChem Diagnostics Inc. MicroAlbuminMAL1010MAL10102018-05-22
00852169008287ClearChem Diagnostics Inc. Hemoglobin A-1cHGB1200HGB12002018-05-22
00852169008058ClearChem Diagnostics Inc. Aspartate aminotransferase (AST)AST1040AST10402018-05-18
00852169008164ClearChem Diagnostics Inc. High-Density Lipoprotein (HDL) CholesterolHDL1210HDL12102018-05-18
00852169008072ClearChem Diagnostics Inc. Carbon Dioxide (CO2)CAR1090CAR10902018-04-30
00852169008027ClearChem Diagnostics Inc. Alkaline Phosphatase (ALP)ALP1010ALP10102018-04-30
00852169008034ClearChem Diagnostics Inc. Alanine aminotransferase (ALT)ALT1020ALT10202018-04-30
00852169008065ClearChem Diagnostics Inc. Blood Urea Nitrogen (BUN)BUN1070BUN10702018-04-30
00852169008089ClearChem Diagnostics Inc. Creatine Kinase (CK)CPK1110CPK11102018-04-30

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