Dade® PFA Trigger Solution B4170-50

GUDID 00842768003691

To aid in the detection of platelet dysfunction in citrated human whole blood

Siemens Healthcare Diagnostics Products GmbH

Platelet aggregation study IVD, reagent

• Primary Device ID: 00842768003691
• NIH Device Record Key: be8e5fc1-34d5-40de-b210-5be8fd9db5f8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dade® PFA Trigger Solution
• Version Model Number: 10445701
• Catalog Number: B4170-50
• Company DUNS: 388240673
• Company Name: Siemens Healthcare Diagnostics Products GmbH
• Device Count: 3
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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: +1(800)242-3233
• Email: XX@XX.XX
• Phone: +1(800)242-3233
• Email: XX@XX.XX
• Phone: +1(800)242-3233
• Email: XX@XX.XX
• Phone: +1(800)242-3233
• Email: XX@XX.XX
• Phone: +1(800)242-3233
• Email: XX@XX.XX
• Phone: +1(800)242-3233
• Email: XX@XX.XX
• Phone: +1(800)242-3233
• Email: XX@XX.XX
• Phone: +1(800)242-3233
• Email: XX@XX.XX
• Phone: +1(800)242-3233
• Email: XX@XX.XX
• Phone: +1(800)242-3233
• Email: XX@XX.XX
• Phone: +1(800)242-3233
• Email: XX@XX.XX
• Phone: +1(800)242-3233
• Email: XX@XX.XX
• Phone: +1(800)242-3233
• Email: XX@XX.XX
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM

Operating and Storage Conditions

• Storage Environment Temperature: Between 16 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 26 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842768003691 [Primary]
GS1	00842768019791 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060489

FDA Product Code

• JOZ: SYSTEM, AUTOMATED PLATELET AGGREGATION

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: 2016-09-24

Devices Manufactured by Siemens Healthcare Diagnostics Products GmbH

• 00842768018800 - BC von Willebrand Reagent: 2024-09-20 Determination of ristocetin co-factor activity of von Willebrand factor in human plasma through platelet agglutination
• 00842768019661 - LA 2 Confirmation Reagent: 2024-04-08 LA 2 Confirmation Reagent. Phospholipid-rich DRVV reagent for the specific correction of Lupus Anticoagulants
• 00842768019654 - LA 1 Screening Reagent: 2024-04-08 LA 1 Screening Reagent. Simplified DRVV reagent to screen for the presence of Lupus Anticoagulants
• 00842768019678 - LA Control Low: 2024-04-08 LA Control Low is a low positive control plasma for use in Lupus Anticoagulant clotting test assays
• 00842768019685 - LA Control High: 2024-04-08 LA Control High is a high positive control plasma for use in Lupus Anticoagulant clotting test assays
• 00630414640433 - vWF Ag: 2024-04-08 For the quantitative determination of von Willebrand factor (vWF) antigen concentration in human sodium citrated plasma
• 00630414639352 - Berichrom Plasminogen: 2024-04-02 Quantitative determination of plasminogen activity as an aid in the diagnosis and monitoring of fibrinolytic disorders
• 00630414639437 - Berichrom a2-Antiplasmin: 2024-04-02 Quantative determination of a2-antiplasmin activity as an aid in the diagnosis of inherited or acquired deficiencies and in mana