ANTI-SCI-70 ORG512

GUDID 04260157080096

ANTI-SCL-70 IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AUTOANTIBODIES AGAINST SCL-70 IN HUMAN SERUM OR PLASMA. THIS PRODUCT

ORGENTEC Diagnostika GmbH

Scleroderma-70 antibody (anti-Scl-70) IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 04260157080096
• NIH Device Record Key: c46a262f-b34a-43eb-be24-3ba539152cc9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ANTI-SCI-70
• Version Model Number: ORG512
• Catalog Number: ORG512
• 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	04260157080096 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K962055

FDA Product Code

• LJM: Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls

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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• 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