Exdia TRF Plus PD-FC20

GUDID 08800026300083

A reader for the Exdia cartridges (immunofluorescence assay).

Precision Biosensor Inc.

Fluorescent immunoassay/spectrophotometry analyser IVD, point-of-care
Primary Device ID08800026300083
NIH Device Record Keydf668127-ebd9-4d7c-be0a-85b2a5510a5b
Commercial Distribution StatusIn Commercial Distribution
Brand NameExdia TRF Plus
Version Model NumberPD-FC20
Catalog NumberPD-FC20
Company DUNS688454363
Company NamePrecision Biosensor Inc.
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 Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800026300083 [Primary]

FDA Product Code

JZTFluorometer

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-24
Device Publish Date2022-11-16

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