CELLTRACKS ANALYZER II 9555

GUDID 10888385000658

CELLTRACKS ANALYZER II - EU ROHS Compliant

MENARINI SILICON BIOSYSTEMS, INC.

Fluorescent immunoassay analyser IVD, laboratory, semi-automated

• Primary Device ID: 10888385000658
• NIH Device Record Key: b7568472-396c-45e5-89a1-4d6dcd6106df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CELLTRACKS ANALYZER II
• Version Model Number: 9555
• Catalog Number: 9555
• Company DUNS: 057722858
• Company Name: MENARINI SILICON BIOSYSTEMS, INC.
• 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: 2153468312
• Email: jclay@siliconbiosystems.com
• Phone: 2153468312
• Email: jclay@siliconbiosystems.com
• Phone: 2153468312
• Email: jclay@siliconbiosystems.com
• Phone: 2153468312
• Email: jclay@siliconbiosystems.com
• Phone: 2153468312
• Email: jclay@siliconbiosystems.com
• Phone: 2153468312
• Email: jclay@siliconbiosystems.com
• Phone: 2153468312
• Email: jclay@siliconbiosystems.com
• Phone: 2153468312
• Email: jclay@siliconbiosystems.com
• Phone: 2153468312
• Email: jclay@siliconbiosystems.com
• Phone: 2153468312
• Email: jclay@siliconbiosystems.com
• Phone: 2153468312
• Email: jclay@siliconbiosystems.com
• Phone: 2153468312
• Email: jclay@siliconbiosystems.com
• Phone: 2153468312
• Email: jclay@siliconbiosystems.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Storage Environment Temperature: Between 2 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Storage Environment Temperature: Between 2 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Storage Environment Temperature: Between 2 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Storage Environment Temperature: Between 2 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Storage Environment Temperature: Between 2 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Storage Environment Temperature: Between 2 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Storage Environment Temperature: Between 2 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Storage Environment Temperature: Between 2 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Storage Environment Temperature: Between 2 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Storage Environment Temperature: Between 2 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Storage Environment Temperature: Between 2 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Storage Environment Temperature: Between 2 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Storage Environment Temperature: Between 2 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888385000658 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130794

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-20
• Device Publish Date: 2020-07-10

Devices Manufactured by MENARINI SILICON BIOSYSTEMS, INC.

• 10888385000061 - CELLTRACKS AUTOPREP: 2022-09-16 AutoPrep Instrument
• 10888385000078 - CELLTRACKS AUTOPREP: 2022-09-16 CellTracks AutoPrep Instrument Buffer
• 10888385000610 - CELLTRACKS AUTOPREP: 2022-09-16 AutoPrep Instrument- Refurbished
• 10888385000658 - CELLTRACKS ANALYZER II: 2020-07-20CELLTRACKS ANALYZER II - EU ROHS Compliant
• 10888385000658 - CELLTRACKS ANALYZER II: 2020-07-20 CELLTRACKS ANALYZER II - EU ROHS Compliant
• 10888385000665 - CELLTRACKS AUTOPREP: 2020-07-20 CELLTRACKS AUTOPREP - EU ROHS Compliant