High-Yield Lyse Fixative-Free Lysing Solution

GUDID 10190302014038

LIFE TECHNOLOGIES CORPORATION

Blood cell lysis reagent IVD

• Primary Device ID: 10190302014038
• NIH Device Record Key: 40a9dd2e-01c4-4759-9ce0-e462dfd711a2
• Commercial Distribution Discontinuation: 2022-04-27
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: High-Yield Lyse Fixative-Free Lysing Solution
• Version Model Number: HYL250
• Company DUNS: 080131636
• Company Name: LIFE TECHNOLOGIES CORPORATION
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10190302014038 [Primary]

FDA Product Code

• GGK: PRODUCTS, RED-CELL LYSING PRODUCTS

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-05-23
• Device Publish Date: 2018-02-02

Devices Manufactured by LIFE TECHNOLOGIES CORPORATION

• 10190302018982 - TaqPath™ COVID-19, Flu A, Flu B, RSV Select Assay: 2025-02-25 Component 1 of 4 of A56123 (Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel)
• 10190302018999 - TaqPath™ COVID-19, Flu A, Flu B, RSV Select Positive Control: 2025-02-25 Component 2 of 4 of A56123 (Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel)
• 10190302019002 - TaqPath™ COVID-19, Flu A, Flu B, RSV Select Negative Control: 2025-02-25 Component 3 of 4 of A56123 (Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel)
• 10190302019019 - TaqPath™ 1-Step Select Master Mix (No ROX): 2025-02-25 Component 4 of 4 of A56123 (Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel)
• 10190302019026 - TaqPath™ COVID-19, Flu A, Flu B, RSV Select Assay: 2025-02-25 Component 1 of 4 of A56124 (Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel)
• 10190302019033 - TaqPath™ COVID-19, Flu A, Flu B, RSV Select Positive Control: 2025-02-25 Component 2 of 4 of A56124 (Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel)
• 10190302019040 - TaqPath™ COVID-19, Flu A, Flu B, RSV Select Negative Control: 2025-02-25 Component 3 of 4 of A56124 (Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel)
• 10190302019057 - TaqPath™ 1-Step Select Master Mix (No ROX): 2025-02-25 Component 4 of 4 of A56124 (Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel)