Phosphate ver.2 05401780190

GUDID 04015630927265

Roche Diagnostics GmbH

Inorganic phosphate (PO43-) IVD, kit, spectrophotometry
Primary Device ID04015630927265
NIH Device Record Key61c05ea1-6363-4b0e-9ca0-591dec590ee4
Commercial Distribution StatusIn Commercial Distribution
Brand NamePhosphate ver.2
Version Model Number5401780190
Catalog Number05401780190
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 Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104015630927265 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CEOPhosphomolybdate (colorimetric), inorganic phosphorus

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-16
Device Publish Date2021-02-08

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