ANTI-CARDIOLIPIN IgA ORG515A

GUDID 04260157080133

Anti-Cardiolipin Screen is an ELISA test system for the quantitative measurement of IgA class autoantibodies against cardiolipin in human serum or pla

ORGENTEC Diagnostika GmbH

Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 04260157080133
• NIH Device Record Key: eea281c8-1550-4a61-8cc8-a1a2b9df8fe4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ANTI-CARDIOLIPIN IgA
• Version Model Number: ORG515A
• Catalog Number: ORG515A
• 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	04260157080133 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K962469

FDA Product Code

• MID: System, Test, Anticardiolipin Immunological

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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