FDA.reportPublic FDA data

Glucose (HK)

Primary DI
16438153817793
Brand
Glucose (HK)
Company
Thermo Fisher Scientific Oy
Model
NONE
Catalog number
981779
Device description
For in vitro diagnostic use in the quantitative determination of the glucose concentration in human serum, plasma or urine on Konelab and Indiko analyzers.
Published
2016-08-30
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
K110035000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110035000INDIKOThermofisher Scientific OY2011-06-28JJE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16438153817793PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1643815381779316438153817793

GMDN Terms#

Term, Definition table
TermDefinition
Glucose IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of glucose in a clinical specimen, using an enzyme spectrophotometry method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
540096708
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
06438153000129Entry, TCA19520152023-07-26
06438153000143Exit, TCA19520162023-07-26
06438153000211Conveyor 600, TCA19520212023-07-26
06438153000228Conveyor 1200, TCA19520222023-07-26
06438153000235Conveyor 1500, TCA19520232023-07-26
06438153000259Conveyor 2400, TCA19520252023-07-26
06438153000266L-Turn, TCA19520272023-07-26
06438153000297Conveyor 900, TCA19520302023-07-26
06438153000303Conveyor 2100, TCA19520312023-07-26
06438153520139Buffer, TCA19520132023-07-26
06438153000099Interface, TCA ARCHITECT i2000SR19522342023-07-25
06438153000242Conveyor 1800, TCA19520242023-07-25
06438153000327Decapper Flex, TCA19520392023-07-25
06438153000358Perpendicular Bypass, TCA Vitros 5.1 FS AT19520432023-07-25
06438153000419Internal U-Turn, TCA19520462023-07-25
06438153000433Z-Turn, right, TCA19520482023-07-25
06438153000440Z-Turn, left, TCA19520492023-07-25
06438153000471Sysmex HST Interface, TCA19520542023-07-25
06438153000488Stago STA-R Interface, TCA19520552023-07-25
06438153000549Parallel Bypass, TCA Vitros 5.1 FS19521312023-07-25

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
00817238011148Glucose UV REAGENTCLINIQA CORPORATIONCFR2018-08-23
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