AMYLASE (CNPG3) Reagent Set 501-400

GUDID 00812137011879

For the quantitative kinetic determination of amylase activity in human serum using a manual or automated procedure. The determination of amylase activity in serum is most commonly performed for the diagnosis and treatment of diseases of the pancreas.

CLINICAL DIAGNOSTIC SOLUTIONS, INC.

Amylase isoenzyme IVD, reagent Amylase isoenzyme IVD, reagent

• Primary Device ID: 00812137011879
• NIH Device Record Key: 89f12aa3-ae3e-418f-9589-1d6fd5f7e91f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMYLASE (CNPG3) Reagent Set
• Version Model Number: 4 x 120 mL
• Catalog Number: 501-400
• Company DUNS: 048144997
• Company Name: CLINICAL DIAGNOSTIC SOLUTIONS, INC.
• Device Count: 4
• DM Exempt: true
• Pre-market Exempt: false
• 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: 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	00812137011879 [Primary]
GS1	00812137012234 [Unit of Use]

FDA Product Code

• CIJ: Saccharogenic, Amylase

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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