Elecsys Progesterone III 7092539190

GUDID 04015630942527

Roche Diagnostics GmbH

Progesterone IVD, kit, chemiluminescent immunoassay
Primary Device ID04015630942527
NIH Device Record Keyb6f6db99-669a-4528-a5ab-4d87843ec31e
Commercial Distribution StatusIn Commercial Distribution
Brand NameElecsys Progesterone III
Version Model Number7092539190
Catalog Number7092539190
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 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

Device Identifiers

Device Issuing AgencyDevice ID
GS104015630942527 [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 Date2021-01-26
Device Publish Date2021-01-18

On-Brand Devices [Elecsys Progesterone III]

040156309425277092539190
0761333621841909755748190

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