Stratus® CS Acute Care™ ßhCG DilPak CBHCG-D

GUDID 00842768004421

The Stratus® CS Acute Care™ Beta human Chorionic Gonadotropin Dilution Pak (ßhCG DilPak), in vitro diagnostic product intended to be used in conjunction with the Acute Care™ ßhCG TestPak on the Stratus® CS analyzer for the measurement of samples with elevated ßhCG levels.

Siemens Healthcare Diagnostics Inc.

Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, fluorescent immunoassay Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, fluorescent immunoassay Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, fluorescent immunoassay Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, fluorescent immunoassay Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, fluorescent immunoassay Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, fluorescent immunoassay Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, fluorescent immunoassay Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, fluorescent immunoassay Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, fluorescent immunoassay Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, fluorescent immunoassay Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, fluorescent immunoassay Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, fluorescent immunoassay Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, fluorescent immunoassay Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, fluorescent immunoassay Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, fluorescent immunoassay Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, fluorescent immunoassay Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, fluorescent immunoassay Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, fluorescent immunoassay Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, fluorescent immunoassay Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, fluorescent immunoassay Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, fluorescent immunoassay Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, fluorescent immunoassay Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, fluorescent immunoassay Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, fluorescent immunoassay Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, fluorescent immunoassay Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, fluorescent immunoassay Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, fluorescent immunoassay Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, fluorescent immunoassay Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, fluorescent immunoassay Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, fluorescent immunoassay

• Primary Device ID: 00842768004421
• NIH Device Record Key: d25d771c-3ff0-44de-af0f-3a972f28bb8e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stratus® CS Acute Care™ ßhCG DilPak
• Version Model Number: 10445062
• Catalog Number: CBHCG-D
• Company DUNS: 005088112
• Company Name: Siemens Healthcare Diagnostics Inc.
• Device Count: 5
• 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)405-6473
• Email: XX@XX.XX
• Phone: +1(800)405-6473
• Email: XX@XX.XX
• Phone: +1(800)405-6473
• Email: XX@XX.XX
• Phone: +1(800)405-6473
• Email: XX@XX.XX
• Phone: +1(800)405-6473
• Email: XX@XX.XX
• Phone: +1(800)405-6473
• Email: XX@XX.XX
• Phone: +1(800)405-6473
• Email: XX@XX.XX
• Phone: +1(800)405-6473
• Email: XX@XX.XX
• Phone: +1(800)405-6473
• Email: XX@XX.XX
• Phone: +1(800)405-6473
• Email: XX@XX.XX
• Phone: +1(800)405-6473
• Email: XX@XX.XX
• Phone: +1(800)405-6473
• Email: XX@XX.XX
• Phone: +1(800)405-6473
• Email: XX@XX.XX
• Phone: +1(800)405-6473
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)405-6473
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)405-6473
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)405-6473
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)405-6473
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)405-6473
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)405-6473
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)405-6473
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)405-6473
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)405-6473
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)405-6473
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)405-6473
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)405-6473
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)405-6473
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)405-6473
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)405-6473
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)405-6473
• Email: CONTACT@SIEMENS-HEALTHINEERS.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
• 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	00630414009773 [Unit of Use]
GS1	00842768004421 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060548

FDA Product Code

• NBC: TEST,NATRIURETIC PEPTIDE

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

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