goldFISH

GUDID 00810202560130

AML1/ETO Dual Color Dual Fusion Probe

Lumatas Biosystems, Inc.

Assay development analyte-specific reagent IVD

• Primary Device ID: 00810202560130
• NIH Device Record Key: 89600e44-edeb-4187-9ec1-66e9ea9ebacb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: goldFISH
• Version Model Number: DF045
• Company DUNS: 080169635
• Company Name: Lumatas Biosystems, Inc.
• 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: true
• 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: 1-510-651-8890
• Email: info@lumatas.com
• Phone: 1-510-651-8890
• Email: info@lumatas.com
• Phone: 1-510-651-8890
• Email: info@lumatas.com
• Phone: 1-510-651-8890
• Email: info@lumatas.com
• Phone: 1-510-651-8890
• Email: info@lumatas.com
• Phone: 1-510-651-8890
• Email: info@lumatas.com
• Phone: 1-510-651-8890
• Email: info@lumatas.com
• Phone: 1-510-651-8890
• Email: info@lumatas.com
• Phone: 1-510-651-8890
• Email: info@lumatas.com
• Phone: 1-510-651-8890
• Email: info@lumatas.com
• Phone: 1-510-651-8890
• Email: info@lumatas.com
• Phone: 1-510-651-8890
• Email: info@lumatas.com
• Phone: 1-510-651-8890
• Email: info@lumatas.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810202560130 [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: 2025-08-11
• Device Publish Date: 2025-08-01

On-Brand Devices [goldFISH]

• 00810202560390: CDKN2C/CKS1B
• 00810202560383: D20S108/20q13
• 00810202560376: TP73/ABL2 Dual Color Probe
• 00810202560369: CHOP Dual Color Break Apart Probe
• 00810202560352: MYB/CSP6 Dual Color Probe
• 00810202560345: MYEOV/IGH Dual Color Dual Fusion Probe
• 00810202560338: FGFR3/IGH Dual Color Dual Fusion Probe
• 00810202560321: MAFB/IGH Dual Color Dual Fusion Probe
• 00810202560314: MAF/IGH Dual Color Dual Fusion Probe
• 00810202560307: ATM/CSP11 Dual Color Probe
• 00810202560291: CTNNB1/CSP3 Dual Color Probe
• 00810202560284: EWSR1/FLI1 Dual Color Dual Fusion Probe
• 00810202560277: EGFR/CSP7 Dual Color Probe
• 00810202560260: ROS1 Dual Color Break Apart Probe
• 00810202560253: PAX3 Dual Color Break Apart Probe
• 00810202560246: FGFR2 Dual Color Break Apart Probe
• 00810202560239: SS18 Dual Color Break Apart Probe
• 00810202560222: EGR1/TERT Dual Color Probe
• 00810202560215: COL1A1/PDGFB Dual Color Dual Fusion Probe
• 00810202560208: MYB Dual Color Break Apart Probe
• 00810202560192: p53/CSP17 Dual Color Probe
• 00810202560185: MDM2/CSP12 Dual Color Probe
• 00810202560178: CDKN2A/CSP9 Dual Color Probe
• 00810202560161: D7S486/CSP7 Dual Color Probe
• 00810202560154: PML/RARA Dual Color Dual Fusion Probe
• 00810202560147: BCR/ABL Dual Color Dual Fusion Probe
• 00810202560130: AML1/ETO Dual Color Dual Fusion Probe
• 00810202560123: MYCN/CSP2 Dual Color Probe
• 00810202560116: EWSR1 Dual Color Break Apart Probe
• 00810202560109: PPARG/CSP3 Dual Color Probe
• 00810202560093: IGH Dual Color Break Apart Probe
• 00810202560086: BCL2/IGH Dual Color Dual Fusion Probe
• 00810202560079: CCND1/IGH Dual Color Dual Fusion Probe
• 00810202560062: IRF4 Dual Color Break Apart Probe
• 00810202560055: BCL6 Dual Color Break Apart Probe
• 00810202560048: BCL2 Dual Color Break Apart Probe
• 00810202560031: MYC Dual Color Break Apart Probe
• 00810202560024: MET/CSP7 Dual Color Probe.
• 00810202560017: ALK Dual Color Break Apart Probe
• 00810202560000: HER2/CSP17 Dual Color Probe