ANTI-PR3 (cANCA) ORG518

GUDID 04260157080171

Anti-PR3 is an ELISA test system for the quantitative measurement of IgG class autoantibodies against proteinase 3 (PR3) in human serum or plasma. Thi

ORGENTEC Diagnostika GmbH

Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD, kit, multiplex

• Primary Device ID: 04260157080171
• NIH Device Record Key: 08c42179-4a5e-4f5c-a757-be8f54a066fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ANTI-PR3 (cANCA)
• Version Model Number: ORG518
• Catalog Number: ORG518
• 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	04260157080171 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K974702

FDA Product Code

• MOB: Test System, Antineutrophil Cytoplasmic Antibodies (Anca)

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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