Simplexa™ Flu A/B & RSV Direct Gen II
GUDID 20816101026962
DIASORIN MOLECULAR LLC
Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus 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
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 20816101026962 [Primary] |
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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