IMMULITE®2000 Systems 3gAllergy™ Coffee F221L2

GUDID 00630414965567

Coffee-Specific IgE - IMMULITE - RGT

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

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

• Primary Device ID: 00630414965567
• NIH Device Record Key: 1610ac38-3333-4544-9d0d-855ee8308485
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMMULITE®2000 Systems 3gAllergy™ Coffee
• Version Model Number: 10385726
• Catalog Number: F221L2
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00630414965567 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091984

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

Devices Manufactured by SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

• 00630414561226 - ADVIA Centaur® HBcT2: 2023-06-28 ADVIA Centaur® HBcT2
• 00630414210766 - ADVIA Centaur® HBcT2 Quality Control Kit: 2023-06-28 ADVIA Centaur® HBcT2
• 00630414604138 - Atellica IM HBcT2: 2023-06-28 HBc Total 2 (HBcT2) Atellica IM - RGT 100T
• 00630414604336 - Atellica IM HBcT2 QC: 2023-06-28 HBc Total 2 (HBcT2) Atellica IM - CLT 2 x 2 x 7.0mL
• 00630414000138 - IMMULITE 2000 rBet v 2 Specific Allergen: 2022-09-20 rBet v 2 Alleren
• 00630414006246 - IMMULITE 2000 rMal d 1 Specific Allergen: 2022-09-20 rMal d 1 Allergen
• 00630414006253 - IMMULITE 2000 rPru av 3 Specific Allergen: 2022-09-20 rPru av 3 Allergen
• 00630414006277 - IMMULITE 2000 rPru av 4 Specific Allergen: 2022-09-20 rPru av 4 Allergen