Simplexa COVID-19 / Flu A/B & RSV Direct MOL4450

GUDID 20816101027358

DIASORIN MOLECULAR LLC

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

• Primary Device ID: 20816101027358
• NIH Device Record Key: c2562e6a-59dc-48bc-96e7-867c0cb406c3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Simplexa COVID-19 / Flu A/B & RSV Direct
• Version Model Number: MOL4450
• Catalog Number: MOL4450
• 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: 15622406500
• Email: TS.Molecular@Diasorin.com
• Phone: 15622406500
• Email: TS.Molecular@Diasorin.com
• Phone: 15622406500
• Email: TS.Molecular@Diasorin.com
• Phone: 15622406500
• Email: TS.Molecular@Diasorin.com
• Phone: 15622406500
• Email: TS.Molecular@Diasorin.com
• Phone: 15622406500
• Email: TS.Molecular@Diasorin.com
• Phone: 15622406500
• Email: TS.Molecular@Diasorin.com
• Phone: 15622406500
• Email: TS.Molecular@Diasorin.com
• Phone: 15622406500
• Email: TS.Molecular@Diasorin.com
• Phone: 15622406500
• Email: TS.Molecular@Diasorin.com
• Phone: 15622406500
• Email: TS.Molecular@Diasorin.com
• Phone: 15622406500
• Email: TS.Molecular@Diasorin.com
• Phone: 15622406500
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	20816101027358 [Primary]

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: 2026-01-22
• Device Publish Date: 2026-01-14

Devices Manufactured by DIASORIN MOLECULAR LLC

• 20816101027358 - Simplexa COVID-19 / Flu A/B & RSV Direct: 2026-01-22
• 20816101027358 - Simplexa COVID-19 / Flu A/B & RSV Direct: 2026-01-22
• 20816101027365 - Simplexa COVID-19 / Flu A/B & RSV Positive Control Pack: 2026-01-22
• 10816101020772 - R. rickettsii Substrate Slide: 2025-12-24
• 10816101027375 - Blastomyces Primer Pair: 2025-12-24
• 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