FDA.reportPublic FDA data

MedTest DX autoHDL for PC180

Primary DI
00817439021151
Brand
MedTest DX autoHDL for PC180
Company
Medtest Dx, Inc.
Model
HDL505
Catalog number
HDL505
Device description
For the quantitative determination high-density lipoprotein cholesterol in human serum or plasma using the Polychem 180 analyzer. For in vitro diagnostic use only. 3 x 51 ml, 2 x 20 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
LBRLdl & Vldl Precipitation, Hdl

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LBRLdl & Vldl Precipitation, HdlClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K992002000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K992002000AUTOHDL CHOLESTEROL REAGENT SETPointe Scientific, Inc.,1999-08-05LBR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817439021151PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817439021151008174390211518174390211510817439021151

GMDN Terms#

Term, Definition table
TermDefinition
Total fatty acid 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 fatty acid 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
06935740725705Blood Lipid AnalyzerUrit Medical Electronic Co., Ltd.LBR2026-06-03
06935740725712Blood Lipid AnalyzerUrit Medical Electronic Co., Ltd.LBR2026-06-03
00682607690053Mission Cholesterol Test Device - 3-in-1 Lipid Panel 25TAcon Laboratories, Inc.LBR2026-03-09
00682607690077Mission Cholesterol Optical Check DeviceAcon Laboratories, Inc.LBR2026-03-09
00682607690084Mission Cholesterol Control SolutionAcon Laboratories, Inc.LBR2026-03-09
00682607690091Mission Cholesterol Test Device - 3-in-1 Lipid Panel 5TAcon Laboratories, Inc.LBR2026-03-09
10682607690050Mission Cholesterol Test Device - 3-in-1 Lipid Panel 25TAcon Laboratories, Inc.LBR2026-03-09
00682607690060Mission Cholesterol MeterAcon Laboratories, Inc.LBR2026-03-09
10682607690081Mission Cholesterol Control SolutionAcon Laboratories, Inc.LBR2026-03-09
06935740726986Blood Lipid Test StripUrit Medical Electronic Co., Ltd.LBR2024-07-12
00850053916175IDG/SanzayIDG/SANZAY CorporationLBR2024-01-12
10673486001907Teco Diagnostics Direct HDL Cholesterol Reagent Kit TC-MatrixTECO DIAGNOSTICSLBR2023-11-20
10673486001938Teco Diagnostics HDL Cholesterol Reagent SetTECO DIAGNOSTICSLBR2023-11-20
10673486001884Teco Diagnostics HDL Cholesterol Reagent SetTECO DIAGNOSTICSLBR2023-11-10
10673486001891Teco Diagnostics Direct HDL Cholesterol Reagent SetTECO DIAGNOSTICSLBR2023-11-10
00381934753010Lipid Panel, 15ct., CCPlus HomePOLYMER TECHNOLOGY SYSTEMS, INC.LBR2023-06-20
00381934752013Lipid + eGLU Smart Bundle™ , CC Plus Home (15-pk)POLYMER TECHNOLOGY SYSTEMS, INC.LBR2023-06-01
00887473000337STANDARD™ LipidoCare Lipid Test Strip - Lipid ProfileSD Biosensor, Inc.LBR2023-05-10
00887473000344STANDARD™ LipidoCare Lipid Test Strip - Lipid ProfileSD Biosensor, Inc.LBR2023-05-10
00887473000320STANDARD™ LipidoCare AnalyzerSD Biosensor, Inc.LBR2023-04-07
00381934747019Assy Vial, Lipid Panel Test Strips, 15 ct, CardioChek Plus HomePOLYMER TECHNOLOGY SYSTEMS, INC.LBR2023-03-25
10381934747016Assy Vial, Lipid Panel Test Strips, 15 ct, CardioChek Plus HomePOLYMER TECHNOLOGY SYSTEMS, INC.LBR2023-03-25
00381934749013Assy Vial, Lipid Panel Test Strips, 1 ct, CardioChek Plus HomePOLYMER TECHNOLOGY SYSTEMS, INC.LBR2023-03-25
00887473000290STANDARD™ LipidoCare Lipid Test Strip - Lipid ProfileSD Biosensor, Inc.LBR2023-03-17
00887473000306STANDARD™ LipidoCare Lipid Test Strip - Lipid ProfileSD Biosensor, Inc.LBR2023-03-17
00887473000283STANDARD™ LipidoCare AnalyzerSD Biosensor, Inc.LBR2023-03-17
00381934750019CardioChek Plus Home Self-Test AnalyzerPOLYMER TECHNOLOGY SYSTEMS, INC.LBR2022-04-11
14987481164533L-Type LDL-C Reagent 1FUJIFILM WAKO PURE CHEMICAL CORPORATIONLBR2021-06-01
14987481164540L-Type LDL-C Reagent 2FUJIFILM WAKO PURE CHEMICAL CORPORATIONLBR2021-06-01
04987481164536L-Type LDL-C Reagent 1FUJIFILM WAKO PURE CHEMICAL CORPORATIONLBR2021-06-01