Elecsys PTH Immunoassay 11972103160

GUDID 04015630939237

Roche Diagnostics GmbH

Parathyroid hormone (PTH) IVD, kit, chemiluminescent immunoassay
Primary Device ID04015630939237
NIH Device Record Key92723ca3-e560-4834-9948-7f4c698debb6
Commercial Distribution StatusIn Commercial Distribution
Brand NameElecsys PTH Immunoassay
Version Model Number11972103160
Catalog Number11972103160
Company DUNS315028860
Company NameRoche Diagnostics GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104015630939237 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CEWRADIOIMMUNOASSAY, PARATHYROID HORMONE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-12-23
Device Publish Date2016-09-20

Devices Manufactured by Roche Diagnostics GmbH

07613336227763 - Sodium electrode2025-03-13
07613336227770 - Potassium electrode2025-03-13
07613336227787 - Chloride electrode2025-03-13
07613336227794 - Reference electrode2025-03-13
07613336183045 - PreciControl Release HIV Gen II2025-02-27
07613336228487 - Elecsys Anti-HBc II2025-02-27
07613336228500 - Elecsys HIV Duo2025-02-27
07613336183212 - PreciControl HIV Gen II2025-02-27

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.