SEPTA, 96 WELL CE-IVD 3500 

GUDID 10190302000260

LIFE TECHNOLOGIES CORPORATION

Nucleic acid hybridization detection IVD, reagent

• Primary Device ID: 10190302000260
• NIH Device Record Key: d38cd25f-bd82-4f7d-be3f-f0a7c957b9a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SEPTA, 96 WELL CE-IVD 3500
• Version Model Number: 4410700
• Company DUNS: 182158873
• Company Name: LIFE TECHNOLOGIES CORPORATION
• Device Count: 20
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10190302000260 [Primary]
GS1	80190302000269 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• BK110039

FDA Product Code

• PCA: DNA genetic analyzer

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-10-23
• Device Publish Date: 2016-08-01

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)