Elecsys Progesterone III 09755748190

GUDID 07613336218419

Roche Diagnostics GmbH

Progesterone IVD, kit, chemiluminescent immunoassay
Primary Device ID07613336218419
NIH Device Record Keyd5ed6dbc-f89c-46b8-854f-53e28fb50631
Commercial Distribution StatusIn Commercial Distribution
Brand NameElecsys Progesterone III
Version Model Number09755748190
Catalog Number09755748190
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
GS107613336218419 [Primary]

FDA Product Code

JLSRADIOIMMUNOASSAY, PROGESTERONE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-06-07
Device Publish Date2024-05-30

On-Brand Devices [Elecsys Progesterone III]

040156309425277092539190
0761333621841909755748190

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