Acucy Calibration Device

Acucy Calibration Device - 1031

A 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.

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Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: PSZ

Device Name: Devices Detecting Influenza A, B, And C Virus Antigens

Device Class: 2

Physical State: Devices detecting influenza A, B, and C virus antigens are in vitro diagnostic devices that consist of reagents and associated instrumentation for the detection and identification of influenza virus antigens

Definition: An influenza virus antigen detection test system is a device intended for the qualitative detection of influenza viral antigens directly from clinical specimens in patients with signs and symptoms of respiratory infection.

Submission Type ID: 1

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: A qualitative in vitro diagnostic assay that detects and identifies influenza virus antigens

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: In vitro diagnostic device

Regulation Number: 866.3328

Third Party Flag: N

Medical Specialty: MI

Device Id: 00742860100345

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A