MRDx BCR-ABL Test 901-0028

GUDID B60290100280

The MRDx Test utilizes quantitative, real-time reverse transcription polymerase chain reaction (RT-qPCR) for BCR-ABL and ABL quantitation. The rapid,

MOLECULARMD CORP.

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• Primary Device ID: B60290100280
• NIH Device Record Key: 99642795-6c90-4012-adca-5328544658ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MRDx BCR-ABL Test
• Version Model Number: 901-0028
• Catalog Number: 901-0028
• Company DUNS: 784311032
• Company Name: MOLECULARMD CORP.
• 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: true
• Device Combination Product: false
• Single Use: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -85 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -85 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -85 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -85 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -85 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -85 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -85 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -85 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -85 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -85 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -85 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -85 Degrees Celsius and -15 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B60290100280 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173492

FDA Product Code

• OYX: Bcr/Abl1 Monitoring Test

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-03-07