FDA.reportPublic FDA data

Glucose UV REAGENT

Primary DI
00817238011148
Brand
Glucose UV REAGENT
Company
CLINIQA CORPORATION
Model
R85411
Device description
Glucose UV REAGENT
Published
2018-08-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
CFRHexokinase, Glucose

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CFRHexokinase, GlucoseClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K012668000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K012668000RAICHEM GLUCOSE UV REAGENTHemagen Diagnostics, Inc.2001-10-15CFR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817238011148PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817238011148008172380111488172380111480817238011148

GMDN Terms#

Term, Definition table
TermDefinition
Glucose 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 glucose in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078742335
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817238010257LiquidQC NEPHROCHECK Control 839382024-06-05
00817238010332NEPHROCHECK Calibration Verification839392024-06-05
00817238010264NEPHROCHECK® Method Validation For VIDAS® 3839402019-01-29
00817238010271LIQUID QC LIPID CONTROL LEVEL 915012018-08-23
00817238010288LIQUID QC LIPID CONTROL LEVEL 2 915022018-08-23
00817238010295LIQUID QC LIPID CONTROL Bi-level 915052018-08-23
00817238011520LQC Cardiac Control CS, mini pack914492022-11-19
00817238011056hsCRP Wide Range Reagent855502018-08-23
00817238010103Tumor Marker Control level 3913032018-08-22
00817238010110Tumor Marker Control level 1 913012018-08-22
00817238010127Tumor Marker Control level 2913022018-08-22
00817238010134Tumor Marker Control Tri-level913042018-08-22
00817238010141ImmuTROL Serum Protein Contrl Tri-Level (Level 1,2 & 3)911042018-08-22
00817238010158Tumor Marker Control Tri-level913092018-08-22
00817238010172ImmuTROL Serum Protein Control-Bi-Level (Level 1 & 3)911052018-08-22
00817238010189ImmuTROL Serum Protein Contrl Level 1911012018-08-22
00817238010196ImmuTROL Serum Protein Contrl Level 2911022018-08-22
00817238010202ImmuTROL Serum Protein Contrl Level 3911032018-08-22
00817238010219hsCRP Serum Protein Control Level 1912012018-08-22
00817238010226hsCRP Serum Protein Control Level 2912022018-08-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414654126Atellica CH GluH_3Siemens Healthcare Diagnostics Inc.CFR2026-03-18
00380740215712AlinityABBOTT LABORATORIESCFR2025-10-08
00850053916113IDG/SanzayIDG/SANZAY CorporationCFR2024-06-25
10673486001693Teco Diagnostics Glucose (Hexokinase) Reagent SetTECO DIAGNOSTICSCFR2023-11-10
10673486001709Teco Diagnostics Glucose (Hexokinase) Reagent SetTECO DIAGNOSTICSCFR2023-11-10
10673486001662Teco Diagnostics Glucose (Hexokinase) Liquid ReagentTECO DIAGNOSTICSCFR2023-11-09
10673486001686Teco Diagnostics Glucose Hexokinase (Liquid) Reagent Kit for TC-MatrixTECO DIAGNOSTICSCFR2023-11-09
07613336161791Glucose HK Gen. 3 Roche Diagnostics GmbHCFR2022-11-18
00811727016157Pointe Glucose ReagentHORIBA INSTRUMENTS INCORPORATEDCFR2021-01-30
00811727015846Pointe Glucose Hexokinase for BS480HORIBA INSTRUMENTS INCORPORATEDCFR2020-05-28
03610230007013Yumizen C1200 Glucose HKHORIBA ABX SASCFR2020-05-06
03610230007020Yumizen C1200 Glucose HKHORIBA ABX SASCFR2020-05-06
07613336121283Glucose HKRoche Diagnostics GmbHCFR2020-03-05
00380740161583ARCHITECTAbbott GmbHCFR2020-01-04
00380740161590ARCHITECTAbbott GmbHCFR2020-01-04
00380740135447AlinityAbbott GmbHCFR2018-07-11
00380740135454AlinityAbbott GmbHCFR2018-07-11
00852169008140ClearChem Diagnostics Inc. GlucoseCLEARCHEM DIAGNOSTICS INC.CFR2018-04-30
00630414596488Atellica CH GluH_3Siemens Healthcare Diagnostics Inc.CFR2017-12-22
00817302023152CLC720 Chemistry Analyzer w/ISECAROLINA LIQUID CHEMISTRIES CORPORATIONCFR2016-12-19
00817302023169CLC480 Chemistry Analyzer W/ISECAROLINA LIQUID CHEMISTRIES CORPORATIONCFR2016-12-19
00817302022995CAROLINA LIQUID CHEMISTRIES CORP.® GLU REAGENT PRODUCT NO. DT208CAROLINA LIQUID CHEMISTRIES CORPORATIONCFR2016-10-17
00812137011985Glucose ReagentCLINICAL DIAGNOSTIC SOLUTIONS, INC.CFR2016-10-12
15099590010195AUBeckman Coulter, Inc.CFR2016-09-24
15099590020101AUBeckman Coulter, Inc.CFR2016-09-24
15099590060084AUBeckman Coulter, Inc.CFR2016-09-24
00842768005541Dimension® Flex® reagent cartridge GLUCSiemens Healthcare Diagnostics Inc.CFR2016-09-24
00842768015663Dimension Vista® Flex® reagent cartridge GLUSiemens Healthcare Diagnostics Inc.CFR2016-09-24
00857969006129ACEALFA WASSERMANN, INC.CFR2016-09-24
00630414526812ADVIA® Chemistry GLUH_3 Glucose Hexokinase_3 ReagentsSiemens Healthcare Diagnostics Inc.CFR2016-09-24