FDA.reportPublic FDA data

GLUCOSE

Primary DI
00628063400539
Brand
GLUCOSE
Company
Sekisui Diagnostics, LLC
Model
SK235-10
Catalog number
SK235-10
Published
2016-09-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
K961282000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K961282000GLUCOSE-SL ASSAY, CATALOGUE NO. 235-60Diagnostic Chemicals , Ltd.1996-06-21CFR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00628063400539PrimaryGS10
10628063400536Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628063400539006280634005396280634005390628063400539
1062806340053610628063400536

GMDN Terms#

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

Regulatory Flags#

DUNS number
966812344
Device count
2
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00742860000027OSOM COVID-19 Antigen Rapid Test1066-401066-402024-12-16
00742860000034OSOM COVID-19 Antigen Control Kit106810682024-12-16
00742860000041OSOM COVID-19 Antigen Home Test1067-401067-402024-12-16
00742860000072OSOM Flu SARS-CoV-2 Combo Control Kit10792024-12-16
00742860000089OSOM Flu SARS-CoV-2 Combo Home107410742024-12-16
00742860100055OSOM BV Blue 25T Kit1831832025-12-29
00742860100314OSOM Vaginal Transport Swab Set1851852018-04-05
00742860100390OSOM ULTRA PLUS FLU A&B Test10322020-06-01
00742860100406OSOM ULTRA PLUS FLU A&B Control Kit10342020-06-01
00742860100673OSOM COVID-19 Test109210922026-01-19
00742860100680OSOM BVBlue Transport Swabs1862026-02-23
00742860100062OSOM BV Blue Control Kit1841842025-12-29
00742860000065OSOM Flu SARS-CoV-2 Combo Test10802024-12-16
00628063401291Acetaminophen03R74202023-05-08
00628063401307Acetaminophen Calibrator03R74012023-05-08
00628063401314Alinity c Acetaminophen07P54202023-05-08
00628063401321Alinity c Acetaminophen Calibrator07P54012023-05-08
00628063401222DC-TROL LEVELS 1 & 2SM-0572020-03-30
00628063401116MicroalbuminSK252-20SK252-202019-10-02
00628063401185Acetaminophen AssaySK507-50SK507-502019-10-02

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