Performance Verification Kit for MeMed Tests Based On TRAIL/ IP-10/ CRP

GUDID 17290018739072

The Performance Verification Kit contains a set of serum-based quantitative samples intended for manual use by healthcare professionals as a reference material to verify the analytical performance (precision, accuracy, and reportable range) of tests based on quantification of TRAIL/ IP-10/ CRP protein concentrations via the MeMed Key® analyzer platform. The performance verification kit is intended for in vitro diagnostic use only.

MEMED DIAGNOSTICS LTD

Multiple cell-mediated host immune response marker IVD, chemiluminescent immunoassay, rapid

• Primary Device ID: 17290018739072
• NIH Device Record Key: 4c7fdec2-8e78-4d79-a159-7991dad2c976
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Performance Verification Kit for MeMed Tests Based On TRAIL/ IP-10/ CRP
• Version Model Number: FG00004
• Company DUNS: 533243445
• Company Name: MEMED DIAGNOSTICS LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and -65 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -65 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -65 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -65 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -65 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -65 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -65 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -65 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -65 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -65 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -65 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -65 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -65 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -65 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -65 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -65 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -65 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -65 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -65 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -65 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -65 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -65 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -65 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -65 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -65 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -65 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -65 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -65 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -65 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -65 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -65 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	17290018739072 [Primary]

FDA Product Code

• JJY: Multi-Analyte Controls, All Kinds (Assayed)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-30
• Device Publish Date: 2022-09-22

Devices Manufactured by MEMED DIAGNOSTICS LTD

• 17290018739089 - MeMed BV® Calibrator: 2023-07-25
• 17290018739072 - Performance Verification Kit for MeMed Tests Based On TRAIL/ IP-10/ CRP: 2022-09-30The Performance Verification Kit contains a set of serum-based quantitative samples intended for manual use by healthcare professionals as a reference material to verify the analytical performance (precision, accuracy, and reportable range) of tests based on quantification of TRAIL/ IP-10/ CRP protein concentrations via the MeMed Key® analyzer platform. The performance verification kit is intended for in vitro diagnostic use only.
• 17290018739072 - Performance Verification Kit for MeMed Tests Based On TRAIL/ IP-10/ CRP: 2022-09-30 The Performance Verification Kit contains a set of serum-based quantitative samples intended for manual use by healthcare profes
• 17290018739010 - MeMed BV®: 2021-12-14
• 17290018739003 - MeMed Key®: 2021-11-03
• 17290018739027 - MeMed BV® Calibrator: 2021-11-03
• 17290018739034 - MeMed BV® External Control: 2021-11-03