FDA.reportPublic FDA data

MedTest DX Lactate Dehydrogenase / BS480

Primary DI
00817439020987
Brand
MedTest DX Lactate Dehydrogenase / BS480
Company
Medtest Dx, Inc.
Model
LDH480
Catalog number
LDH480
Device description
Lactate Dehydrogenase, for the in vitro quantitative kinetic determination of lactate dehydrogenase activity in serum using the Mindray BS-480 analyzer. Size: 4 x 40 ml, 4 x 10 ml.
Published
2016-09-27
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K973589000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K973589000LIQUID LDH-L REAGENT SETPointe Scientific, Inc.,1997-10-08CFJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817439020987PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817439020987008174390209878174390209870817439020987

GMDN Terms#

Term, Definition table
TermDefinition
Total lactate dehydrogenase (LDH) IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of total lactate dehydrogenase (LDH) 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

Contacts#

Phone, Email table
PhoneEmail
800-445-9853techservice@medtest.com

Regulatory Flags#

DUNS number
070371210
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
00817439020000Direct Lipid Control Set300030002016-09-27
00817439020017Direct Lipid Control L1300130012016-09-27
00817439020024Direct Lipid Control L2300230022016-09-27
00817439020031Direct Lipid Control L3300330032016-09-27
00817439020062Wash Concentrate 103W50003W5002016-09-27
00817439020079Wash Concentrate 209W50009W5002016-09-27
00817439020086Wash Concentrate 310W50010W5002016-09-27
00817439020093Albumin / BS480ALB480ALB4802016-09-27
00817439020109AlbuminALB505ALB5052016-09-27
00817439020116Albumin / BS200ALB600ALB6002016-09-27
00817439020123Alkaline Phos/ BS480ALP480ALP4802016-09-27
00817439020130ALP ReagentALP505ALP5052016-09-27
00817439020147MedTest DX Alkaline PhosphataseALP600ALP6002016-09-27
00817439020192Amylase / BS480AMY480AMY4802016-09-27
00817439020215Amylase / BS200AMY600AMY6002016-09-27
00817439020222AST / BS480AST480AST4802016-09-27
00817439020239AST / Polychem 180AST505AST5052016-09-27
00817439020246AST / BS200AST600AST6002016-09-27
00817439020314C1 Cleaning SolutionC1S500C1S5002016-09-27
00817439020321Calibrator Level 1 CA1100CA11002016-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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06971674863366BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CFJ2023-07-21
06971674863373BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CFJ2023-07-21
06971674863380BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CFJ2023-07-21
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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
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