FDA.reportPublic FDA data

Pointe Lactate Dehydrogenase Reagent

Primary DI
00811727015907
Brand
Pointe Lactate Dehydrogenase Reagent
Company
HORIBA INSTRUMENTS INCORPORATED
Model
14-L7572-200
Catalog number
14-L7572-200
Device description
Pointe Lactate Dehydrogenase Reagent packaged for use on the Mindray BS480. 4 x 40ml R1, 4 x 10ml R2. For the in vitro quantitative kinetic determination of lactate dehydrogenase activity in serum.
Published
2021-01-30
Public version status
Update
Distribution status
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
00811727015907PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811727015907008117270159078117270159070811727015907

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@medtestdx.com

Regulatory Flags#

DUNS number
052845583
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
00811727018977POINTE Chemistry Calibrator SetC7506-15C7506-152026-05-01
00811727015716Pointe ALT for the BS48014-A7526-37514-A7526-3752020-05-28
00811727015747Pointe BUN on BS48014-B7552-60014-B7552-6002020-05-28
00811727015761Pointe Creatinine Enzymatic on BS48014-C7548-21614-C7548-2162020-05-28
00811727015785Pointe Creatine Kinase for BS48014-C7522-22014-C7522-2202020-05-28
00811727015808Pointe Creatinine for BS48014-C7539-43214-C7539-4322020-05-28
00811727015822Pointe Direct Bilirubin for BS48014-HB936-20014-HB936-2002020-05-28
00811727015853Pointe HbA1c for the BS48014-H7546-16014-H7546-1602020-05-28
00811727015709Pointe Alkaline Phosphatase on the BS48014-A7516-22514-A7516-2252020-05-28
00811727015723Pointe Amylase on BS480 Analyzer14-A7564-12014-A7564-1202020-05-28
00811727015730Pointe AST on the BS480 Analyzer14-A7561-37514-A7561-3752020-05-28
00811727015754Pointe Calcium Arsenazo for BS48014-C7529-36014-C7529-3602020-05-28
00811727015778Pointe Cholesterol on BS48014-C7510-48014-C7510-4802020-05-28
00811727015792Pointe Carbon Dioxide on the BS48014-C7502-16014-C7502-1602020-05-28
00811727015839Pointe GGT on BS48014-G7571-20014-G7571-2002020-05-28
00811727015846Pointe Glucose Hexokinase for BS48014-G7517-48014-G7517-4802020-05-28
00811727015860Pointe autoHDL for the BS48014-H7545-30014-H7545-4002020-05-28
00811727015877Pointe Homocysteine for BS48014-H7575-14414-H7575-1442020-05-28
00811727015884Pointe Total Iron for the BS48014-HI904-35014-HI904-3502020-05-28
00811727015693Pointe Albumin on BS480 Analyzer14-A7502-48014-A7502-4802020-05-28

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Primary DI, Brand, Company table
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00850053916137IDG/SanzayIDG/SANZAY CorporationCFJ2024-01-12
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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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