Glucose Reagent 501-411

GUDID 00812137011985

For the in vitro quantitative measurement of glucose in serum. The measurement of glucose concentrations in biological fluids has been well documented. Glucose testing can be diagnostically significant in diabetes, hypoglycemia, and various adrenal and pituitary disorders.

CLINICAL DIAGNOSTIC SOLUTIONS, INC.

Glucose IVD, reagent

• Primary Device ID: 00812137011985
• NIH Device Record Key: 1aa251a0-6f99-44e6-a954-2847d4f9fb12
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Glucose Reagent
• Version Model Number: 500mL
• Catalog Number: 501-411
• Company DUNS: 048144997
• Company Name: CLINICAL DIAGNOSTIC SOLUTIONS, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8004533328
• Email: quality@cdsolinc.com
• Phone: 8004533328
• Email: quality@cdsolinc.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	00812137011985 [Primary]

FDA Product Code

• CFR: Hexokinase, Glucose

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-10-12

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