FDA.reportPublic FDA data

MedTest DX Lipoprotein (a) Calibrator for the BS480

Primary DI
00817439021090
Brand
MedTest DX Lipoprotein (a) Calibrator for the BS480
Company
Medtest Dx, Inc.
Model
LPAC480
Catalog number
LPAC480
Device description
Lipoprotein(a) calibrator series is an in vitro diagnostic product for the calibration of Lipoprotein(a). 5 x 1 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
DFCLipoprotein, Low-Density, Antigen, Antiserum, Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DFCLipoprotein, Low-Density, Antigen, Antiserum, ControlImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K013359000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K013359000LP(A)-LATEX SEIKEN ASSAY KITDenka Seiken'S2002-03-08DFC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817439021090PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817439021090008174390210908174390210900817439021090

GMDN Terms#

Term, Definition table
TermDefinition
Lipoprotein A 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 lipoprotein A lipid 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
800-445-9853techservice@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
07613336237380Tina-quant Lipoprotein (a) Gen.2 MolarityRoche Diagnostics GmbHDFC2025-05-27
07613336237397Tina-quant Lipoprotein (a) Gen.2 MolarityRoche Diagnostics GmbHDFC2025-05-27
07613336237403Tina-quant Lipoprotein (a) Gen.2 MolarityRoche Diagnostics GmbHDFC2025-05-27
08058056680211Lp(a) UltraSENTINEL CH. SPADFC2024-03-15
05055273204445LIPOPROTEIN (a) CONTROL (Lp (a) CONTROL 3) RANDOX LABORATORIES LIMITEDDFC2022-10-05
00380740170165ARCHITECTABBOTT IRELANDDFC2022-03-16
00380740170158AlinityABBOTT IRELANDDFC2021-05-19
00811727015921Pointe Lp(a) ReagentHORIBA INSTRUMENTS INCORPORATEDDFC2021-01-30
00811727016225Pointe Lp(a) ReagentHORIBA INSTRUMENTS INCORPORATEDDFC2021-01-30
00380740175146ARCHITECTAbbott GmbHDFC2020-12-15
07613336140833Tina-quant Lipoprotein (a) Gen.2Roche Diagnostics GmbHDFC2020-03-16
07613336133538Tina-quant Apolipoprotein B ver.2Roche Diagnostics GmbHDFC2020-03-05
00380740156435ARCHITECTABBOTT LABORATORIESDFC2020-03-03
00380740154509AlinityAbbott GmbHDFC2019-09-09
00380740153847AlinityABBOTT LABORATORIESDFC2019-05-10
00817302022308CAROLINA LIQUID CHEMISTRIES CORP.® Lipoprotein (a) Assay KitCAROLINA LIQUID CHEMISTRIES CORPORATIONDFC2018-09-07
00817302022315CAROLINA LIQUID CHEMISTRIES CORP.® Lipoprotein (a) Assay KitCAROLINA LIQUID CHEMISTRIES CORPORATIONDFC2018-09-07
00630414595559Atellica CH Lp(a)Siemens Healthcare Diagnostics Inc.DFC2017-12-21
00817439021069MedTest Dx, Inc. Lp (a)Medtest Dx, Inc.DFC2016-09-27
05055273204421Lp (a)RANDOX LABORATORIES LIMITEDDFC2016-09-26
05051700016841Lipoprotein (a) Kit for use on SPAPLUSTHE BINDING SITE GROUP LIMITEDDFC2016-09-24
05055273204384Lp (a)RANDOX LABORATORIES LIMITEDDFC2016-09-24
00842768007552N Latex Lp(a) ReagentSiemens Healthcare Diagnostics Products GmbHDFC2016-09-24
05391516743938Trinity BiotechCLARK LABORATORIES, INC.DFC2016-09-23
04015630917730Tinaquant Apolipoprotein B ver2Roche Diagnostics GmbHDFC2016-09-20
04015630917754Tinaquant Apolipoprotein B ver2Roche Diagnostics GmbHDFC2016-09-20
04015630928668Tinaquant Apolipoprotein B ver2Roche Diagnostics GmbHDFC2016-09-20
04015630929962Tinaquant Lipoprotein a Gen.2Roche Diagnostics GmbHDFC2016-09-20
04015630930234Tinaquant Apolipoprotein B ver2Roche Diagnostics GmbHDFC2016-09-20
04015630930586Tinaquant Lipoprotein a Gen.2Roche Diagnostics GmbHDFC2016-09-20