Diabetes Antigen Control (Unassayed) 10-1134-01

GUDID 07350108630078

Mercodia Diabetes Antigen Control is designed to be used as a two-level control for human insulin, C-peptide and proinsulin. It is manufactured from human serum and human insulin, C-peptide and proinsulin.

Mercodia AB

Insulin IVD, control Multiple insulin synthesis pathway analyte IVD, control Multiple insulin synthesis pathway analyte IVD, control Multiple insulin synthesis pathway analyte IVD, control Multiple insulin synthesis pathway analyte IVD, control Multiple insulin synthesis pathway analyte IVD, control Multiple insulin synthesis pathway analyte IVD, control Multiple insulin synthesis pathway analyte IVD, control Multiple insulin synthesis pathway analyte IVD, control Multiple insulin synthesis pathway analyte IVD, control Multiple insulin synthesis pathway analyte IVD, control Multiple insulin synthesis pathway analyte IVD, control Multiple insulin synthesis pathway analyte IVD, control Multiple insulin synthesis pathway analyte IVD, control Multiple insulin synthesis pathway analyte IVD, control Multiple insulin synthesis pathway analyte IVD, control

• Primary Device ID: 07350108630078
• NIH Device Record Key: fc872c3b-547a-407e-a47b-309be21ec9d3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Diabetes Antigen Control (Unassayed)
• Version Model Number: 10-1134-01
• Catalog Number: 10-1134-01
• Company DUNS: 354553091
• Company Name: Mercodia AB
• 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: true
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +4618570070
• Email: info@mercodia.com
• Phone: +4618570070
• Email: info@mercodia.com
• Phone: +4618570070
• Email: info@mercodia.com
• Phone: +4618570070
• Email: info@mercodia.com
• Phone: +4618570070
• Email: info@mercodia.com
• Phone: +4618570070
• Email: info@mercodia.com
• Phone: +4618570070
• Email: info@mercodia.com
• Phone: +4618570070
• Email: info@mercodia.com
• Phone: +4618570070
• Email: info@mercodia.com
• Phone: +4618570070
• Email: info@mercodia.com
• Phone: +4618570070
• Email: info@mercodia.com
• Phone: +4618570070
• Email: info@mercodia.com
• Phone: +4618570070
• Email: info@mercodia.com
• Phone: +4618570070
• Email: info@mercodia.com
• Phone: +4618570070
• Email: info@mercodia.com
• Phone: +4618570070
• Email: info@mercodia.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
• 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	07350108630078 [Primary]

FDA Product Code

• OHQ: Multi-Analyte Controls Unassayed

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: 2020-04-16
• Device Publish Date: 2020-04-08

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• 07350108630023 - Mercodia Insulin ELISA: 2020-04-16 Mercodia Insulin ELISA provides a method for the quantitative determination of human insulin in serum or plasma.
• 07350108630030 - Mercodia Insulin ELISA 10 pack: 2020-04-16 Mercodia Insulin ELISA provides a method for the quantitative determination of human insulin in serum or plasma.
• 07350108630047 - Insulin ELISA Kit (DAKO): 2020-04-16 Insulin ELISA Kit provides a method for the quantitative determination of human insulin in serum or plasma. As with all diagnost
• 07350108630054 - Mercodia Iso-Insulin ELISA: 2020-04-16 Mercodia Iso-Insulin ELISA provides a method for the quantitative determination of insulin in human serum or plasma.
• 07350108630061 - Mercodia Ultrasensitive Insulin ELISA: 2020-04-16 Mercodia Ultrasensitive Insulin ELISA provides a method for the quantitative determination of insulin in human serum or plasma.