HER2 IQFISH pharmDx™

GUDID 05700572032465

Dako Denmark ApS

Her2/neu/erbB2 mRNA expression IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 05700572032465
• NIH Device Record Key: 22d4b094-db5e-45cf-8253-3c4dbb5f0846
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HER2 IQFISH pharmDx™
• Version Model Number: K5731
• Company DUNS: 305047466
• Company Name: Dako Denmark ApS
• 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: 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: false
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 0 Degrees Celsius and -18 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 0 Degrees Celsius and -18 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 0 Degrees Celsius and -18 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 0 Degrees Celsius and -18 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 0 Degrees Celsius and -18 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 0 Degrees Celsius and -18 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 0 Degrees Celsius and -18 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 0 Degrees Celsius and -18 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 0 Degrees Celsius and -18 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 0 Degrees Celsius and -18 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 0 Degrees Celsius and -18 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 0 Degrees Celsius and -18 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 0 Degrees Celsius and -18 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 0 Degrees Celsius and -18 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	05700572032465 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P040005

FDA Product Code

• MVD: System, Test, Her-2/Neu, Nucleic Acid Or Serum

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-03-13
• Device Publish Date: 2014-09-15

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