IMMULITE® 2000 Systems aBC Calibration Verification Material Anti-HBC L2MCCVM

GUDID 00630414978017

Anti-HBc IgM CVM - IMMULITE - CONS

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control

• Primary Device ID: 00630414978017
• NIH Device Record Key: 95efffc1-5e56-4b8c-9d65-f962c4520d7d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMMULITE® 2000 Systems aBC Calibration Verification Material Anti-HBC
• Version Model Number: 10373676
• Catalog Number: L2MCCVM
• Company DUNS: 296822794
• Company Name: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
• 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: 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(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM

Operating and Storage Conditions

• Handling Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00630414978017 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P030040

FDA Product Code

• LOM: Test, hepatitis b (b core, be antigen, be antibody, b core igm)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-01-01
• Device Publish Date: 2018-12-01

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