BCS® System Cuvette Rotors OVIP15

GUDID 00842768014444

The BCS Cuvette Rotor is part of the BCS-XP system.

Siemens Healthcare Diagnostics Products GmbH

Coagulation analyser IVD, laboratory, automated

• Primary Device ID: 00842768014444
• NIH Device Record Key: 4f2122d2-e5a8-45f7-8a66-4129f11884c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BCS® System Cuvette Rotors
• Version Model Number: 10446524
• Catalog Number: OVIP15
• Company DUNS: 388240673
• Company Name: Siemens Healthcare Diagnostics Products GmbH
• Device Count: 126
• 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: true
• 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: 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
• 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 2 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842768014444 [Primary]
GS1	00842768024603 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K970431

FDA Product Code

• GKP: INSTRUMENT, COAGULATION, AUTOMATED

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: 2017-10-31

Devices Manufactured by Siemens Healthcare Diagnostics Products GmbH

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• 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