FDA.reportPublic FDA data

ClearChem Diagnostics Inc. Protein, Total

Primary DI
00852169008249
Brand
ClearChem Diagnostics Inc. Protein, Total
Company
CLEARCHEM DIAGNOSTICS INC.
Model
TPR1310
Catalog number
TPR1310
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
CEKBIURET (COLORIMETRIC), TOTAL PROTEIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CEKBiuret (Colorimetric), Total ProteinClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852169008249PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852169008249008521690082498521690082490852169008249

GMDN Terms#

Term, Definition table
TermDefinition
Total protein 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 protein 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
00630414654010Atellica CH Total Protein_2Siemens Healthcare Diagnostics Inc.CEK2026-03-18
00850053916144IDG/SanzayIDG/SANZAY CorporationCEK2024-01-12
00630414611082Atellica CH Total Protein_2Siemens Healthcare Diagnostics Inc.CEK2023-12-13
00630414306025Atellica CH Total Protein_2Siemens Healthcare Diagnostics Inc.CEK2023-12-13
10673486002171Teco Diagnostics CSF/Urine Protein Reagent SetTECO DIAGNOSTICSCEK2023-11-14
10673486002201Teco Diagnostics Total Protein Reagent SetTECO DIAGNOSTICSCEK2023-11-14
10673486002218Teco Diagnostics Total Protein Reagent Kit for TC-MatrixTECO DIAGNOSTICSCEK2023-11-14
06971674862215BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEK2023-07-21
06971674862222BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEK2023-07-21
06971674862239BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEK2023-07-21
06971674862246BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEK2023-07-21
06971674862253BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEK2023-07-21
06971674862260BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEK2023-07-21
06971674862277BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEK2023-07-21
06971674862284BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEK2023-07-21
06971674862291BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEK2023-07-21
06971674862307BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEK2023-07-21
06971674862314BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEK2023-07-21
06971674862321BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEK2023-07-21
06971674862338BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEK2023-07-21
06971674862352BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEK2023-07-21
06971674862369BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEK2023-07-21
06971674862376BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEK2023-07-21
06971674862383BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEK2023-07-21
05055273206531TOTAL PROTEIN (TP)RANDOX LABORATORIES LIMITEDCEK2022-10-05
05055273206555TOTAL PROTEIN (TP)RANDOX LABORATORIES LIMITEDCEK2022-10-05
05055273206562TOTAL PROTEIN 2 (TP 2)RANDOX LABORATORIES LIMITEDCEK2022-10-05
00380740155469ARCHITECTABBOTT IRELANDCEK2022-07-12
00380740155476ARCHITECTABBOTT IRELANDCEK2022-07-12
00380740155261AlinityABBOTT IRELANDCEK2022-06-30