Simplexa™ C. auris Direct MOL3950
GUDID 20816101027198
DIASORIN MOLECULAR LLC
Candida auris nucleic acid IVD, kit, nucleic acid technique (NAT)| Primary Device ID | 20816101027198 |
| NIH Device Record Key | 6ab36d59-2acf-44b9-b46b-496c1f298b6c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Simplexa™ C. auris Direct |
| Version Model Number | MOL3950 |
| Catalog Number | MOL3950 |
| 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
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 |
| Storage Environment Temperature | Between -30 Degrees Celsius and -10 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 20816101027198 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- deNovo: DEN230092
FDA Product Code
| SBT | Device To Detect Microbial Colonization Directly From Clinical Specimens. |
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 | 2024-07-29 |
| Device Publish Date | 2024-07-19 |
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 |
| 20816101027198 - Simplexa™ C. auris Direct | 2024-07-29 |
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 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.