Iron Reagent Set 501-412

GUDID 00812137011992

For the quantitative determination of iron in serum. For in vitro diagnostic use only.

CLINICAL DIAGNOSTIC SOLUTIONS, INC.

Iron IVD, reagent Iron IVD, reagent

• Primary Device ID: 00812137011992
• NIH Device Record Key: 3836e05d-fb2e-4aba-9a99-420b89bdf5ef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Iron Reagent Set
• Version Model Number: R1 x 500mL, R2 x 15mL
• Catalog Number: 501-412
• Company DUNS: 048144997
• Company Name: CLINICAL DIAGNOSTIC SOLUTIONS, INC.
• Device Count: 2
• 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: true
• 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	00812137011992 [Primary]
GS1	00812137012326 [Unit of Use]

FDA Product Code

• JIY: Photometric Method, Iron (Non-Heme)

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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