IMMULITE® Systems dc2 CONTROL 3gAllergy™ Specific IgE Positive Control for D2 DC2LCM

GUDID 00630414984575

Specific IgE D2 - IMMULITE - CTL - 1x4mL

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Allergen-specific immunoglobulin E (IgE) antibody IVD, control Allergen-specific immunoglobulin E (IgE) antibody IVD, control Allergen-specific immunoglobulin E (IgE) antibody IVD, control Allergen-specific immunoglobulin E (IgE) antibody IVD, control Allergen-specific immunoglobulin E (IgE) antibody IVD, control Allergen-specific immunoglobulin E (IgE) antibody IVD, control Allergen-specific immunoglobulin E (IgE) antibody IVD, control Allergen-specific immunoglobulin E (IgE) antibody IVD, control Allergen-specific immunoglobulin E (IgE) antibody IVD, control Allergen-specific immunoglobulin E (IgE) antibody IVD, control Allergen-specific immunoglobulin E (IgE) antibody IVD, control Allergen-specific immunoglobulin E (IgE) antibody IVD, control Allergen-specific immunoglobulin E (IgE) antibody IVD, control Allergen-specific immunoglobulin E (IgE) antibody IVD, control Allergen-specific immunoglobulin E (IgE) antibody IVD, control Allergen-specific immunoglobulin E (IgE) antibody IVD, control Allergen-specific immunoglobulin E (IgE) antibody IVD, control Allergen-specific immunoglobulin E (IgE) antibody IVD, control Allergen-specific immunoglobulin E (IgE) antibody IVD, control Allergen-specific immunoglobulin E (IgE) antibody IVD, control Allergen-specific immunoglobulin E (IgE) antibody IVD, control Allergen-specific immunoglobulin E (IgE) antibody IVD, control Allergen-specific immunoglobulin E (IgE) antibody IVD, control Allergen-specific immunoglobulin E (IgE) antibody IVD, control Allergen-specific immunoglobulin E (IgE) antibody IVD, control Allergen-specific immunoglobulin E (IgE) antibody IVD, control Allergen-specific immunoglobulin E (IgE) antibody IVD, control Allergen-specific immunoglobulin E (IgE) antibody IVD, control Allergen-specific immunoglobulin E (IgE) antibody IVD, control Allergen-specific immunoglobulin E (IgE) antibody IVD, control Allergen-specific immunoglobulin E (IgE) antibody IVD, control Allergen-specific immunoglobulin E (IgE) antibody IVD, control Allergen-specific immunoglobulin E (IgE) antibody IVD, control Allergen-specific immunoglobulin E (IgE) antibody IVD, control Allergen-specific immunoglobulin E (IgE) antibody IVD, control Allergen-specific immunoglobulin E (IgE) antibody IVD, control Allergen-specific immunoglobulin E (IgE) antibody IVD, control Allergen-specific immunoglobulin E (IgE) antibody IVD, control Allergen-specific immunoglobulin E (IgE) antibody IVD, control

• Primary Device ID: 00630414984575
• NIH Device Record Key: 3349131e-ac44-4145-8a85-abbb61ed11e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMMULITE® Systems dc2 CONTROL 3gAllergy™ Specific IgE Positive Control for D2
• Version Model Number: 10485105
• Catalog Number: DC2LCM
• 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: 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(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: 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
• 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

• 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
• 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	00630414984575 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K013134

FDA Product Code

• DHB: SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) 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: 4
• Public Version Date: 2019-02-06
• Device Publish Date: 2016-09-24

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