CytoCell myProbes

GUDID 05055844909373

P16 in Gold Spectrum

CYTOCELL LIMITED

Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD

• Primary Device ID: 05055844909373
• NIH Device Record Key: 0250b0ac-a327-4115-aa2f-2c96cd370c99
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CytoCell myProbes
• Version Model Number: MPD2763
• Company DUNS: 232477914
• Company Name: CYTOCELL LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Manufacturing Date: false
• Expiration Date: false
• 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: 9144675285
• Email: probes@cytocell.com
• Phone: 9144675285
• Email: probes@cytocell.com
• Phone: 9144675285
• Email: probes@cytocell.com
• Phone: 9144675285
• Email: probes@cytocell.com
• Phone: 9144675285
• Email: probes@cytocell.com
• Phone: 9144675285
• Email: probes@cytocell.com
• Phone: 9144675285
• Email: probes@cytocell.com
• Phone: 9144675285
• Email: probes@cytocell.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the probe and counterstain vials in the dark. Ensure that exposure of the probe and counterstain to laboratory lights is limited at all times.
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the probe and counterstain vials in the dark. Ensure that exposure of the probe and counterstain to laboratory lights is limited at all times.
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the probe and counterstain vials in the dark. Ensure that exposure of the probe and counterstain to laboratory lights is limited at all times.
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the probe and counterstain vials in the dark. Ensure that exposure of the probe and counterstain to laboratory lights is limited at all times.
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the probe and counterstain vials in the dark. Ensure that exposure of the probe and counterstain to laboratory lights is limited at all times.
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the probe and counterstain vials in the dark. Ensure that exposure of the probe and counterstain to laboratory lights is limited at all times.
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the probe and counterstain vials in the dark. Ensure that exposure of the probe and counterstain to laboratory lights is limited at all times.
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the probe and counterstain vials in the dark. Ensure that exposure of the probe and counterstain to laboratory lights is limited at all times.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055844909373 [Primary]

FDA Product Code

• MVU: Reagents, Specific, Analyte

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: 2022-12-08
• Device Publish Date: 2022-11-30

On-Brand Devices [CytoCell myProbes]

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• 05055844914544: BSG in Gold Spectrum
• 05055844914537: MIR-181 in FITC Spectrum
• 05055844914520: MIR-373 in Aqua Spectrum
• 05055844914513: USP6 Distal in FITC Spectrum
• 05055844914506: USP6 Proximal in Texas Red Spectrum
• 05055844914490: 10cen in FITC Spectrum
• 05055844914483: FGFR2 in Texas Red Spectrum
• 05055844914476: 17c in FITC Spectrum
• 05055844914469: HER2 in Texas Red Spectrum
• 05055844914452: ETV6 in FITC Spectrum
• 05055844914445: NTRK3 in Texas Red Spectrum
• 05055844914438: BCL10 Distal in FITC Spectrum
• 05055844914421: BCL10 Proximal in Texas Red Spectrum
• 05055844914414: 12cen in FITC Spectrum
• 05055844914407: CDK4 in Texas Red Spectrum
• 05055844914391: 17cen in FITC Spectrum
• 05055844914384: SPAG5 in Texas Red Spectrum
• 05055844914377: CCND3 in Aqua Spectrum
• 05055844914360: MYB in Texas Red Spectrum
• 05055844914353: SEC63 in FITC Spectrum
• 05055844914346: CARD11 in Aqua Spectrum
• 05055844914339: FAS in Texas Red Spectrum
• 05055844914322: DNMT3 in FITC Spectrum
• 05055844914315: 17cen in FITC Spectrum
• 05055844914308: MIEN1/GRB7 in Texas Red Spectrum
• 05055844914292: WWTR1 (TAZ) Distal in Orange Spectrum
• 05055844914285: WWTR1 (TAZ) Proximal in FITC Spectrum
• 05055844914278: WWTR1 (TAZ) Proximal in FITC Spectrum
• 05055844914261: NTRK1 Proximal in Aqua Spectrum
• 05055844914254: NTRK3 in Aqua Spectrum
• 05055844914247: NTRK2 Proximal in FITC Spectrum
• 05055844914230: NTRK2 Distal in Texas Red Spectrum
• 05055844914223: 1cen in Orange Spectrum
• 05055844914216: BARTTIN (BSND) in FITC Spectrum
• 05055844914209: 7cen in Orange Spectrum
• 05055844914193: CDK6 in FITC Spectrum
• 05055844914186: 12cen in Orange Spectrum
• 05055844914179: CDK4 in FITC Spectrum
• 05055844914162: 1q31.1 in Aqua Spectrum
• 05055844914155: 1q41 in FITC Spectrum
• 05055844914148: 1q32.1 in Orange Spectrum
• 05055844914131: 1p36.21 in Aqua Spectrum
• 05055844914124: 1p32.2 in FITC Spectrum
• 05055844914117: 1p21.2 in Orange Spectrum
• 05055844914100: MET Proximal in FITC Spectrum
• 05055844914094: MET Distal in Texas Red Spectrum
• 05055844914087: PLAG1 Distal FITC Spectrum
• 05055844914070: PLAG1 Proximal in Texas Red Spectrum