Exdia TRF Plus

Primary DI
08800026300083
Brand
Exdia TRF Plus
Company
Precision Biosensor Inc.
Model
PD-FC20
Catalog number
PD-FC20
Device description
A reader for the Exdia cartridges (immunofluorescence assay).
Published
2022-11-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JZTFluorometer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JZTFluorometerImmunology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800026300083PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800026300083088000263000838800026300083

GMDN Terms#

Term, Definition table
TermDefinition
Fluorescent immunoassay/spectrophotometry analyser IVD, point-of-careA portable, electrically-powered point-of-care instrument typically used to scan an immunoassay reagent vehicle (e.g., test strip, cassette, or card) after exposure to a clinical specimen, to provide a quantitative and/or qualitative in vitro determination of cells and/or markers, chemical substances and/or biological markers in a clinical specimen. The instrument detects fluorescent markers that result from the immunological reaction between the reagents and the specimen and uses a spectrophotometric method to measure the absorbance of chemical and/or biological markers. It is mostly used for rapid in vitro diagnostic measurements at the point-of-care or in the laboratory.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
688454363
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260157630949B.R.A.H.M.S KRYPTOR compact PLUS B.R.A.H.M.S GmbHJZT2016-08-17
04260157633216B.R.A.H.M.S KRYPTOR compact SOLUTION 1 B.R.A.H.M.S GmbHJZT2016-08-17
04260157633223B.R.A.H.M.S KRYPTOR compact SOLUTION 2 B.R.A.H.M.S GmbHJZT2016-08-17
04260157633230B.R.A.H.M.S KRYPTOR compact SOLUTION 3 B.R.A.H.M.S GmbHJZT2016-08-17
04260157633247B.R.A.H.M.S KRYPTOR compact SOLUTION 4B.R.A.H.M.S GmbHJZT2016-08-17
04260157638976B.R.A.H.M.S KRYPTOR compact REACTB.R.A.H.M.S GmbHJZT2016-08-17
04260157638983B.R.A.H.M.S KRYPTOR compact DILCUPB.R.A.H.M.S GmbHJZT2016-08-17
04260157638990B.R.A.H.M.S KRYPTOR BUFFERB.R.A.H.M.S GmbHJZT2016-08-17