Elecsys PTH CalSet 11972219122

GUDID 04015630913121

Roche Diagnostics GmbH

Parathyroid hormone (PTH) IVD, calibrator
Primary Device ID04015630913121
NIH Device Record Key6b4d61b3-472d-4366-8400-a90aa18664c6
Commercial Distribution StatusIn Commercial Distribution
Brand NameElecsys PTH CalSet
Version Model Number11972219122
Catalog Number11972219122
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
GS104015630913121 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JITCALIBRATOR, SECONDARY

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

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