β-Hydroxybutyrate 21 Bi-Level Controls 595409943084

GUDID 04051839002921

For use as controls in quantative procedures for β-Hydroxybutyrate

DiaSys Diagnostic Systems GmbH

Beta-hydroxybutyrate IVD, control

• Primary Device ID: 04051839002921
• NIH Device Record Key: b6ace5fa-9e0d-4126-b955-cbb9203ac214
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: β-Hydroxybutyrate 21 Bi-Level Controls
• Version Model Number: 595409943084
• Catalog Number: 595409943084
• Company DUNS: 328419718
• Company Name: DiaSys Diagnostic Systems GmbH
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04051839002921 [Primary]

FDA Product Code

• JJX: Single (Specified) Analyte Controls (Assayed And Unassayed)

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: 2018-12-17
• Device Publish Date: 2018-11-15

Devices Manufactured by DiaSys Diagnostic Systems GmbH

• 04051839002891 - β-Hydroxybutyrate 21 FS: 2018-12-17 For the quantitative determination of beta-hydroxybutyrate in human serum or plasma.
• 04051839002907 - β-Hydroxybutyrate 21 FS: 2018-12-17 For the quantitative determination of beta-hydroxybutyrate in human serum or plasma.
• 04051839002921 - β-Hydroxybutyrate 21 Bi-Level Controls: 2018-12-17For use as controls in quantative procedures for β-Hydroxybutyrate
• 04051839002921 - β-Hydroxybutyrate 21 Bi-Level Controls: 2018-12-17 For use as controls in quantative procedures for β-Hydroxybutyrate
• 04051839002938 - β-Hydroxybutyrate 21 Linearity Standards: 2018-12-17 For use as linearity standards in quantitative procedures for β-Hydroxybutyrate
• 04051839002914 - β-Hydroxybutyrate 21 Tri-Level Controls: 2018-11-29 For use as controls in quantitative procedures for β-Hydroxybutyrate