FDA.reportPublic FDA data

Thermo Scientific Infinity™

Primary DI
00845275002423
Brand
Thermo Scientific Infinity™
Company
Fisher Diagnostics
Model
TR15421
Published
2016-09-16
Public version status
Update
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
CFRHexokinase, Glucose

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CFRHexokinase, GlucoseClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K980026000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K980026000GLUCOSE (HK) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)Trace America, Inc.1998-03-10CFR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845275002423PrimaryGS10
00845275006162Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845275002423008452750024238452750024230845275002423
00845275006162008452750061628452750061620845275006162

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.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-528-0494xx@xx.xx

Regulatory Flags#

DUNS number
183998769
Device count
2
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00845275002751Thermo Scientific Infinity™TR254212016-09-16
00845275000504Thermo Scientific Pacific Hemostasis®1003012016-09-16
00845275000559Thermo Scientific Pacific Hemostasis®1005952016-09-16
00845275000566Thermo Scientific Pacific Hemostasis®1005962016-09-16
00845275000573Thermo Scientific Pacific Hemostasis®1005972016-09-16
00845275000580Thermo Scientific Pacific Hemostasis®1006012016-09-16
00845275000634Thermo Scientific Pacific Hemostasis®1003082016-09-16
00845275000658Thermo Scientific Pacific Hemostasis®1003122016-09-16
00845275000818Thermo Scientific Pacific Hemostasis®1005602016-09-16
00845275000832Thermo Scientific Pacific Hemostasis®1006032016-09-16
00845275000849Thermo Scientific Pacific Hemostasis®1006062016-09-16
00845275000016Infinity Ammonia Reagent for Beckman Coulter AU Chemistry Analyzers OSR611542025-11-18
00845275000405Thermo Scientific TR360262016-09-16
00845275001068Thermo Scientific 12452502016-09-16
00845275002973Thermo Scientific TR333212016-09-16
00845275005431Thermo Scientific for Beckman Coulter SYNCHRON and UnuCel SystemsA466602016-09-16
00845275004717Thermo Scientific Nerl®JDIL55222019-08-13
00845275003031Thermo Scientific Infinity™TR351212016-09-16
00845275000528Thermo Scientific Pacific Hemostasis®1003532016-09-16
00845275000535Thermo Scientific Pacific Hemostasis®1003542016-09-16

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