Simplexa Congenital CMV Direct MOL2255

GUDID 20816101025835

DIASORIN MOLECULAR LLC

Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT) Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT) Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT) Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT) Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT) Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT) Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT) Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT) Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT) Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT) Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT) Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT) Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT) Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT) Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT) Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT) Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT) Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 20816101025835
• NIH Device Record Key: 4b71e27c-e41f-447d-b5b9-5d4191d20058
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Simplexa Congenital CMV Direct
• Version Model Number: MOL2255
• Catalog Number: MOL2255
• 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: 562-240-6500
• Email: TS.molecular@diasorin.com
• Phone: 562-240-6500
• Email: TS.molecular@diasorin.com
• Phone: 562-240-6500
• Email: TS.molecular@diasorin.com
• Phone: 562-240-6500
• Email: TS.molecular@diasorin.com
• Phone: 562-240-6500
• Email: TS.molecular@diasorin.com
• Phone: 562-240-6500
• Email: TS.molecular@diasorin.com
• Phone: 562-240-6500
• Email: TS.molecular@diasorin.com
• Phone: 562-240-6500
• Email: TS.molecular@diasorin.com
• Phone: 562-240-6500
• Email: TS.molecular@diasorin.com
• Phone: 562-240-6500
• Email: TS.molecular@diasorin.com
• Phone: 562-240-6500
• Email: TS.molecular@diasorin.com
• Phone: 562-240-6500
• Email: TS.molecular@diasorin.com
• Phone: 562-240-6500
• Email: TS.molecular@diasorin.com
• Phone: 562-240-6500
• Email: TS.molecular@diasorin.com
• Phone: 562-240-6500
• Email: TS.molecular@diasorin.com
• Phone: 562-240-6500
• Email: TS.molecular@diasorin.com
• Phone: 562-240-6500
• Email: TS.molecular@diasorin.com
• Phone: 562-240-6500
• Email: TS.molecular@diasorin.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	20816101025835 [Primary]

FDA Product Code

• QDZ: Qualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital Cytomegalovirus Infection

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: 2023-06-26
• Device Publish Date: 2023-06-16

Devices Manufactured by DIASORIN MOLECULAR LLC

• 20816101027143 - Simplexa COVID-19 & Flu A/B Direct: 2023-07-03
• 20816101025835 - Simplexa Congenital CMV Direct: 2023-06-26
• 20816101025835 - Simplexa Congenital CMV Direct: 2023-06-26
• 20816101025842 - Simplexa Congenital CMV Positive Control Pack: 2023-06-26
• 20816101027020 - Simplexa COVID-19 Direct: 2023-06-26
• 20816101027037 - Simplexa COVID-19 Positive Control Pack: 2023-06-26
• 20816101027150 - Simplexa COVID-19 & Flu A/B Positive Control Pack: 2023-06-26
• 10816101022295 - DxSelect™ - Substrate Reagent: 2023-06-02
• 10816101025111 - Universal Disc Cover Tape: 2021-12-08