FDA.reportPublic FDA data

Thermo Scientific

Primary DI
00845275002591
Brand
Thermo Scientific
Company
Fisher Diagnostics
Model
TR20015
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
CFJNad Reduction/Nadh Oxidation, Lactate Dehydrogenase

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CFJNad Reduction/Nadh Oxidation, Lactate DehydrogenaseClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K860728000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K860728000L D H-L (LACTIC DEHYDROGENASE) REAGENTTrace Scientific , Ltd.1986-04-07CFJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845275002591PrimaryGS10
00845275006179Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845275002591008452750025918452750025910845275002591
00845275006179008452750061798452750061790845275006179

GMDN Terms#

Term, Definition table
TermDefinition
Total lactate dehydrogenase (LDH) 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 lactate dehydrogenase (LDH) 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
20
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00845275000542Thermo Scientific Pacific Hemostasis®1003562016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380740155322AlinityABBOTT IRELANDCFJ2025-12-19
00380740155339AlinityABBOTT IRELANDCFJ2025-12-19
00380740195236ARCHITECTABBOTT IRELANDCFJ2025-12-19
00380740195243ARCHITECTABBOTT IRELANDCFJ2025-12-19
00850053916137IDG/SanzayIDG/SANZAY CorporationCFJ2024-01-12
10673486002027Teco Diagnostics LDH Liquid Reagent Kit for TC MatrixTECO DIAGNOSTICSCFJ2023-11-13
10673486002034Teco Diagnostics Lactate Dehydrogenase (LDH-L) Liquid Reagent SetTECO DIAGNOSTICSCFJ2023-11-13
10673486002041Teco Diagnostics LDH Liquid Reagent Kit for TC MatrixTECO DIAGNOSTICSCFJ2023-11-13
10673486002058Teco Diagnostics LDH Liquid Reagent Kit for TC MatrixTECO DIAGNOSTICSCFJ2023-11-13
10673486002065Teco Diagnostics LDH-L Reagent SetTECO DIAGNOSTICSCFJ2023-11-13
10673486002072Teco Diagnostics LDH-L Reagent SetTECO DIAGNOSTICSCFJ2023-11-13
06971674863267BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CFJ2023-07-21
06971674863274BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CFJ2023-07-21
06971674863281BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CFJ2023-07-21
06971674863298BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CFJ2023-07-21
06971674863304BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CFJ2023-07-21
06971674863311BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CFJ2023-07-21
06971674863328BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CFJ2023-07-21
06971674863335BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CFJ2023-07-21
06971674863342BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CFJ2023-07-21
06971674863359BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CFJ2023-07-21
06971674863366BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CFJ2023-07-21
06971674863373BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CFJ2023-07-21
06971674863380BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CFJ2023-07-21
00811727015891Pointe Lactate Reagent HORIBA INSTRUMENTS INCORPORATEDCFJ2021-01-30
00811727015907Pointe Lactate Dehydrogenase ReagentHORIBA INSTRUMENTS INCORPORATEDCFJ2021-01-30
00811727016195Pointe Lactic Acid ReagentHORIBA INSTRUMENTS INCORPORATEDCFJ2021-01-30
00811727016201Pointe Lactate Dehydrogenase ReagentHORIBA INSTRUMENTS INCORPORATEDCFJ2021-01-30
03610230007075Yumizen C1200 LDHHORIBA ABX SASCFJ2020-08-28
10758750031108VITROSORTHO-CLINICAL DIAGNOSTICS, INC.CFJ2020-04-18