Simplexa COVID-19 & Flu A/B Direct MOL4250

GUDID 20816101027143

DIASORIN MOLECULAR LLC

Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 20816101027143
• NIH Device Record Key: c0ef7b1e-4ee5-4238-90ff-7d286c432ff9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Simplexa COVID-19 & Flu A/B Direct
• Version Model Number: MOL4250
• Catalog Number: MOL4250
• Company DUNS: 080271715
• Company Name: DIASORIN MOLECULAR LLC
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 5622406500
• Email: TS.molecular@diasorin.com
• Phone: 5622406500
• Email: TS.molecular@diasorin.com
• Phone: 5622406500
• Email: TS.molecular@diasorin.com
• Phone: 5622406500
• Email: TS.molecular@diasorin.com
• Phone: 5622406500
• Email: TS.molecular@diasorin.com
• Phone: 5622406500
• Email: TS.molecular@diasorin.com
• Phone: 5622406500
• Email: TS.molecular@diasorin.com
• Phone: 5622406500
• Email: TS.molecular@diasorin.com
• Phone: 5622406500
• Email: TS.molecular@diasorin.com
• Phone: 5622406500
• Email: TS.molecular@diasorin.com
• Phone: 5622406500
• Email: TS.molecular@diasorin.com
• Phone: 5622406500
• Email: TS.molecular@diasorin.com
• Phone: 5622406500
• Email: TS.molecular@diasorin.com
• Phone: 5622406500
• Email: TS.molecular@diasorin.com
• Phone: 5622406500
• Email: TS.molecular@diasorin.com
• Phone: 5622406500
• Email: TS.molecular@diasorin.com
• Phone: 5622406500
• Email: TS.molecular@diasorin.com
• Phone: 5622406500
• Email: TS.molecular@diasorin.com
• Phone: 5622406500
• Email: TS.molecular@diasorin.com
• Phone: 5622406500
• Email: TS.molecular@diasorin.com
• Phone: 5622406500
• Email: TS.molecular@diasorin.com
• Phone: 5622406500
• Email: TS.molecular@diasorin.com
• Phone: 5622406500
• Email: TS.molecular@diasorin.com
• Phone: 5622406500
• Email: TS.molecular@diasorin.com
• Phone: 5622406500
• Email: TS.molecular@diasorin.com
• Phone: 5622406500
• Email: TS.molecular@diasorin.com
• Phone: 5622406500
• Email: TS.molecular@diasorin.com
• Phone: 5622406500
• Email: TS.molecular@diasorin.com
• Phone: 5622406500
• Email: TS.molecular@diasorin.com
• Phone: 5622406500
• Email: TS.molecular@diasorin.com
• Phone: 5622406500
• Email: TS.molecular@diasorin.com
• Phone: 5622406500
• Email: TS.molecular@diasorin.com
• Phone: 5622406500
• Email: TS.molecular@diasorin.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	20816101027143 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220963

FDA Product Code

• QOF: Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents

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: 2023-07-03
• Device Publish Date: 2023-06-23

Devices Manufactured by DIASORIN MOLECULAR LLC

• 20816101027136 - Simplexa COVID-19 Positive Control GEN II Pack: 2025-09-25
• 10816101027313 - Measles Virus Primer Pair: 2025-05-20
• 10816101027306 - Borrelia miyamotoi Primer Pair: 2024-12-31
• 10816101027207 - Factor V HyBeacon II Primer Pair: 2024-10-02
• 10816101027221 - Prothrombin (FII) HyBeacon Gen II Primer Pair: 2024-10-02
• 10816101027283 - Monkeypox Primer Pair: 2024-08-30
• 10816101027290 - Human GAPDH Endogenous Primer Pair: 2024-08-30
• 20816101027198 - Simplexa™ C. auris Direct: 2024-07-29