TDM/B-Hydroxybutyrate Linearity Standards 2450-604

GUDID 00657498000557

For Use as Linearity Standards in Quantitative Procedures for Acetaminophen, Salicylate, Theophylline, and ß-Hydroxybutyrate.

STANBIO LABORATORY, L.P.

Beta-hydroxybutyrate IVD, calibrator

• Primary Device ID: 00657498000557
• NIH Device Record Key: a7ecbe3d-540e-4104-ae11-fac7153ee4f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TDM/B-Hydroxybutyrate Linearity Standards
• Version Model Number: 2450-604
• Catalog Number: 2450-604
• Company DUNS: 045361136
• Company Name: STANBIO LABORATORY, L.P.
• 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: true
• 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

Customer Support Contacts

• Phone: 18005315535
• Email: stanbiolab@ekfdiagnostics.com
• Phone: 18005315535
• Email: stanbiolab@ekfdiagnostics.com

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00657498000557 [Primary]

FDA Product Code

• DKB: Calibrators, Drug Mixture

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-04-16
• Device Publish Date: 2016-09-23

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