CELLTRACKS AUTOPREP 7901003

GUDID 10888385000078

CellTracks AutoPrep Instrument Buffer

MENARINI SILICON BIOSYSTEMS, INC.

Specimen processing instrument IVD

• Primary Device ID: 10888385000078
• NIH Device Record Key: 163ac4e0-dfaa-4f53-8446-a39bdb1d4a22
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CELLTRACKS AUTOPREP
• Version Model Number: 7901003
• Catalog Number: 7901003
• Company DUNS: 057722858
• Company Name: MENARINI SILICON BIOSYSTEMS, INC.
• Device Count: 1
• DM Exempt: true
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(877)837-4339
• Email: xx@xx.xx
• Phone: +1(877)837-4339
• Email: xx@xx.xx
• Phone: +1(877)837-4339
• Email: xx@xx.xx
• Phone: +1(877)837-4339
• Email: xx@xx.xx
• Phone: +1(877)837-4339
• Email: xx@xx.xx
• Phone: +1(877)837-4339
• Email: xx@xx.xx
• Phone: +1(877)837-4339
• Email: xx@xx.xx
• Phone: +1(877)837-4339
• Email: xx@xx.xx
• Phone: +1(877)837-4339
• Email: xx@xx.xx
• Phone: +1(877)837-4339
• Email: xx@xx.xx
• Phone: +1(877)837-4339
• Email: xx@xx.xx
• Phone: +1(877)837-4339
• Email: xx@xx.xx
• Phone: +1(877)837-4339
• Email: xx@xx.xx
• Phone: +1(877)837-4339
• Email: xx@xx.xx

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888385000078 [Primary]

FDA Product Code

• NQI: SYSTEM, IMMUNOMAGNETIC, CIRCULATING CANCER CELL, ENUMERATION

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: 2022-09-16
• Device Publish Date: 2016-09-22

On-Brand Devices [CELLTRACKS AUTOPREP]

• 10888385000665: CELLTRACKS AUTOPREP - EU ROHS Compliant
• 10888385000610: AutoPrep Instrument- Refurbished
• 10888385000078: CellTracks AutoPrep Instrument Buffer
• 10888385000061: AutoPrep Instrument