GLP systems Track 04Z9651

GUDID 00380740196257

GLP IN/OUT MODULE (IOM)

ABBOTT LABORATORIES

Specimen processing instrument IVD

• Primary Device ID: 00380740196257
• NIH Device Record Key: 7ecbc795-dc31-4378-89d7-7601c2768629
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GLP systems Track
• Version Model Number: 04Z9651
• Catalog Number: 04Z9651
• Company DUNS: 079226220
• Company Name: ABBOTT LABORATORIES
• 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: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx

Operating and Storage Conditions

• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00380740196257 [Primary]

FDA Product Code

• JQP: Calculator/data processing module, for clinical use

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: 2023-09-07
• Device Publish Date: 2023-08-30

Devices Manufactured by ABBOTT LABORATORIES

• 00380740220495 - ARCHITECT: 2025-08-11 ARCHITECT cSystems Assay Disk Conventional Units version 23.0
• 00380740220501 - ARCHITECT: 2025-08-11 ARCHITECT cSystems Assay Disk SI Units version 23.0
• 00380740202798 - Alinity: 2025-07-29 Alinity s Anti-HCV II Calibrator Kit
• 00380740203108 - Alinity: 2025-07-29 Alinity s Anti-HCV II Assay Control Kit
• 00380740203115 - Alinity: 2025-07-29 Alinity s Anti-HCV II Release Control Kit
• 00380740203139 - Alinity: 2025-07-29 Alinity s Anti-HCV II Reagent Kit
• 00380740190644 - ARCHITECT: 2025-04-23 ARCHITECT Chol2 Conventional Units e-Assay CD-ROM version 1.0
• 00380740190651 - ARCHITECT: 2025-04-23 ARCHITECT Chol2 SI Units e-Assay CD-ROM version 1.0