β-Hydroxybutyrate 21 FS 137119943018

GUDID 04051839002891

For the quantitative determination of beta-hydroxybutyrate in human serum or plasma.

DiaSys Diagnostic Systems GmbH

Beta-hydroxybutyrate IVD, kit, enzyme spectrophotometry

• Primary Device ID: 04051839002891
• NIH Device Record Key: 8f6c5c34-0279-4eff-8e26-16588b337303
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: β-Hydroxybutyrate 21 FS
• Version Model Number: 137119943018
• Catalog Number: 137119943018
• 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
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04051839002891 [Primary]

FDA Product Code

• JIN: Nitroprusside, Ketones (Urinary, Non-Quant.)

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

On-Brand Devices [β-Hydroxybutyrate 21 FS]

• 04051839002907: For the quantitative determination of beta-hydroxybutyrate in human serum or plasma.
• 04051839002891: For the quantitative determination of beta-hydroxybutyrate in human serum or plasma.