Simplexa™ Flu A/B & RSV Direct Gen II
GUDID 20816101026962
DIASORIN MOLECULAR LLC
Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)| Primary Device ID | 20816101026962 |
| NIH Device Record Key | 2091dd67-be65-4b71-8b11-22f81ace3c1e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Simplexa™ Flu A/B & RSV Direct Gen II |
| Version Model Number | MOL2655 |
| 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 | true |
| 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
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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 20816101026962 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K201505
FDA Product Code
| OCC | Respiratory Virus Panel Nucleic Acid Assay System |
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 | 2020-09-07 |
| Device Publish Date | 2020-08-29 |
Devices Manufactured by DIASORIN MOLECULAR LLC
Trademark Results [Simplexa]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SIMPLEXA 79070362 3811076 Dead/Cancelled |
Theben AG 2009-04-27 |
 SIMPLEXA 77444256 3818926 Live/Registered |
DIASORIN MOLECULAR LLC 2008-04-09 |
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