MedTest DX autoHDL for PC180 HDL505

GUDID 00817439021151

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

Medtest Dx, Inc.

Total fatty acid IVD, reagent Total fatty acid IVD, reagent Total fatty acid IVD, reagent
Primary Device ID00817439021151
NIH Device Record Key4d2c242c-9142-4326-929d-f68dd77fbc0d
Commercial Distribution StatusIn Commercial Distribution
Brand NameMedTest DX autoHDL for PC180
Version Model NumberHDL505
Catalog NumberHDL505
Company DUNS070371210
Company NameMedtest Dx, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-445-9853
Emailtechservice@medtest.com
Phone800-445-9853
Emailtechservice@medtest.com
Phone800-445-9853
Emailtechservice@medtest.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100817439021151 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LBRLdl & Vldl Precipitation, Hdl

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-27

Devices Manufactured by Medtest Dx, Inc.

00817439020000 - Direct Lipid Control Set2018-07-06 This product is intended for in-vitro use only, in the quality control of Direct HDL, Direct LDL, Lipoprotein (a), and Apolipopr
00817439020024 - Direct Lipid Control L22018-07-06 This product is intended for in-vitro use only, in the quality control of Direct HDL, Direct LDL, Lipoprotein (a), and Apolipopr
00817439020031 - Direct Lipid Control L32018-07-06 This product is intended for in-vitro use only, in the quality control of Direct HDL, Direct LDL, Lipoprotein (a), and Apolipopr
00817439020093 - Albumin / BS4802018-07-06 For the quantitative determination of Albumin in serum using the Mindray BS-480 analyzer. In vitro diagnostic medical device. 8
00817439020109 - Albumin2018-07-06 For the quantitative in vitro determination of Albumin in serum and plasma on the Polychem 180 analyzer. 9 x 51 ml
00817439020116 - Albumin / BS2002018-07-06 For the quantitative determination of Albumin in serum using the Mindray BS-200 analyzer. 4 x 40 ml
00817439020123 - Alkaline Phos/ BS4802018-07-06 For the quantitative determination of Albumin in serum using the Mindray BS-480 analyzer. In vitro diagnostic medical device.
00817439020130 - ALP Reagent2018-07-06 For the quantitative in vitro determination of Alkaline Phosphatase (ALP) in serum and plasma. 6 x 51 ml, 6 x 14 ml

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.