CalSet PTH 08928452190

GUDID 07613336170311

Roche Diagnostics GmbH

Parathyroid hormone (PTH) IVD, calibrator
Primary Device ID07613336170311
NIH Device Record Keydc4c5981-5dec-48ae-8f27-522400dede97
Commercial Distribution StatusIn Commercial Distribution
Brand NameCalSet PTH
Version Model Number08928452190
Catalog Number08928452190
Company DUNS315028860
Company NameRoche Diagnostics GmbH
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 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

Device Identifiers

Device Issuing AgencyDevice ID
GS107613336170311 [Primary]

FDA Product Code

JJXSingle (specified) analyte controls (assayed and unassayed)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-07
Device Publish Date2024-07-30

On-Brand Devices [CalSet PTH]

0761333614767208243875190
0401563094077607360894190
0761333617031108928452190

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