ANTI-dsDNA ORG604

GUDID 04260157080683

Anti-dsDNA is an ELISA test system for the quantitative measurement of IgG class autoantibodies against double-stranded DNA in human serum or plasma.

ORGENTEC Diagnostika GmbH

Double stranded DNA antibody (anti-dsDNA) IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 04260157080683
• NIH Device Record Key: f715c9f2-1712-4fa1-a6f8-70b1cb941d65
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ANTI-dsDNA
• Version Model Number: ORG604
• Catalog Number: ORG604
• Company DUNS: 328133103
• Company Name: ORGENTEC Diagnostika GmbH
• Device Count: 1
• DM Exempt: false
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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: +49061319258
• Email: BARBARA.MANSI@ORGENTEC.COM
• Phone: +49061319258
• Email: BARBARA.MANSI@ORGENTEC.COM
• Phone: +49061319258
• Email: BARBARA.MANSI@ORGENTEC.COM
• Phone: +49061319258
• Email: BARBARA.MANSI@ORGENTEC.COM
• Phone: +49061319258
• Email: BARBARA.MANSI@ORGENTEC.COM
• Phone: +49061319258
• Email: BARBARA.MANSI@ORGENTEC.COM
• Phone: +49061319258
• Email: BARBARA.MANSI@ORGENTEC.COM
• Phone: +49061319258
• Email: BARBARA.MANSI@ORGENTEC.COM
• Phone: +49061319258
• Email: BARBARA.MANSI@ORGENTEC.COM
• Phone: +49061319258
• Email: BARBARA.MANSI@ORGENTEC.COM
• Phone: +49061319258
• Email: BARBARA.MANSI@ORGENTEC.COM
• Phone: +49061319258
• Email: BARBARA.MANSI@ORGENTEC.COM
• Phone: +49061319258
• Email: BARBARA.MANSI@ORGENTEC.COM
• Phone: +49061319258
• Email: BARBARA.MANSI@ORGENTEC.COM
• Phone: +49061319258
• Email: BARBARA.MANSI@ORGENTEC.COM
• Phone: +49061319258
• Email: BARBARA.MANSI@ORGENTEC.COM
• Phone: +49061319258
• Email: BARBARA.MANSI@ORGENTEC.COM
• Phone: +49061319258
• Email: BARBARA.MANSI@ORGENTEC.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
• 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	04260157080683 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K953671

FDA Product Code

• LRM: Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control

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: 2018-07-06
• Device Publish Date: 2016-08-31

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• 04260157080027 - ANTI-TPO: 2018-07-06 ANTI-TPO IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AUTOANTIBODIES AGAINST THYROID PEROXIDASE (TPO) I
• 04260157080034 - ENASCREEN: 2018-07-06 ENASCREEN IS AN ELISA TEST SYSTEM FOR THE QUALITATIVE SCREENING OF IgG CLASS AUTOANTIBODIES AGAINST EXTRACABLE NUCLEAR ANTIGENS
• 04260157080058 - ANTI-SS-A: 2018-07-06 ANTI-SS-A IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AUTOANTIBODIES AGAINST SS-A (52 AND 60kDa) IN HU
• 04260157080065 - ANTI-SS-B: 2018-07-06 ANTI-SS-B IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AUTOANTIBODIES AGAINST SS-B (La) IN HUMAN SERUM
• 04260157080072 - ANTI-SM: 2018-07-06 ANTI-SM IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AUTOANTIBODIES AGAINST SM IN HUMAN SERUM OR PLASMA
• 04260157080089 - ANTI-RPN/SM: 2018-07-06 ANTI-RPN/SM IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AUTOANTIBODIES AGAINST RNP/SM IN HUMAN SERUM O