FDA.report

ProciseDx Analyzer

Primary DI
08100322943909
Brand
ProciseDx Analyzer
Company
PROCISEDX Inc.
Model
4390
Device description
The ProciseDx Analyzer is intended for use with Procise assay cartridges manufactured by ProciseDx Inc. for the in vitro diagnosis and quantification of various targets or conditions in human patients. The ProciseDx Analyzer should be used in accordance with user documentation and facility specific regulations. For in vitro diagnostic use only.
Published
2024-08-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
DCKC-Reactive Protein, Antigen, Antiserum, And Control

Product Code Classifications

CodeDeviceSpecialtyClass
DCKC-Reactive Protein, Antigen, Antiserum, And ControlImmunology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08100322943909PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08100322943909081003229439098100322943909

GMDN Terms

TermDefinition
Fluorescent immunoassay analyser IVD, laboratoryAn electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers in a clinical specimen. The instrument detects fluorescent markers that result from an immunological reaction between the reagents and the specimen, and typically includes an autosampler, reagent dispenser, light source, filter or monochromator, a fluorescent detection system (fluorometer or spectrofluorometer), data processing and/or data display software.

Storage And Handling

TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius55 Degrees Celsius
Storage Environment Temperature-4 Degrees Fahrenheit130 Degrees Fahrenheit

Sterilization Methods

Method

Regulatory Flags

DUNS number
117361503
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
true
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
08100322953854Procise IFX53852024-08-16
08100322954301Procise ADL54302024-08-16
08100322954295ProciseDx Calibration Cartridge54292024-08-06

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