MAS PTH Control Liquid Assayed PTH Control

GUDID 00884883004078

Microgenics Corporation

Parathyroid hormone (PTH) IVD, control
Primary Device ID00884883004078
NIH Device Record Key0ed09c8f-8d10-48b2-96fe-2bbd393598ff
Commercial Distribution StatusIn Commercial Distribution
Brand NameMAS PTH Control Liquid Assayed PTH Control
Version Model NumberPTH-MP
Company DUNS122153799
Company NameMicrogenics Corporation
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100884883004078 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-12-23
Device Publish Date2017-04-26

Devices Manufactured by Microgenics Corporation

00884883008830 - MAS Diabetes Max-SP (Sample-Pack)2024-05-29
00884883008823 - MAS Diabetes Max, Multi-pack2024-05-28
00884883006027 - Acrometrix BB NAT HBV Positive Control2022-10-17
00884883007376 - MAS omni Infectious BSI Positive Control Panel for use with Siemens Assays2021-11-11
07613336190791 - OXY DRI Oxycodone2021-11-03
00884883007383 - MAS anti-HBs Positive Control – For use with Siemens Assays 2021-05-13
00884883007765 - MAS SARS-CoV-2 IgG Positive Control2021-03-15
00884883007772 - MAS SARS-CoV-2 Negative Control2021-03-15

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