FDA.report

ProciseDx Calibration Cartridge

Primary DI
08100322954295
Brand
ProciseDx Calibration Cartridge
Company
PROCISEDX Inc.
Model
5429
Device description
The ProciseDx Calibration Cartridge is an accessory with quantitative assigned values to the ProciseDx Analyzer and is used to confirm that the instrument is operating within specified limits. The calibration cartridge does not contact biological specimens and is not used for diagnostic testing. The intended users are clinical laboratory professionals responsible for completing a periodic calibration check of the ProciseDx Analyzer.
Published
2024-08-06
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
08100322954295PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08100322954295081003229542958100322954295

GMDN Terms

TermDefinition
Optical laboratory instrument performance standard calibrator/control IVD, reusableA solid phase or liquid reference standard of known optical and physical characteristics intended to be used to verify and/or optimise the performance of an optical laboratory instrument (e.g., spectrophotometer, nephelometer, microplate reader). It is typically presented as a solid/sealed cuvette or a multiple-well test plate and may include filters or a light source emitted at specified wavelengths. Verification/optimization functions may include optical density (absorbance/scattering), fluorescent or luminescent accuracy, linearity, repeatability and/or limit of detection readings, and optical alignment and precision of the instrument/analyser. This is a reusable device.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

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
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
08100322943909ProciseDx Analyzer43902024-08-05

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