FDA UDI
In Commercial Distribution
🇺🇸 United States
Simplexa COVID-19 & Flu A/B Direct
DI: 20816101027143
·
Model: MOL4250
·
DIASORIN MOLECULAR LLC
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Simplexa COVID-19 & Flu A/B Direct
- Primary DI
- 20816101027143
- Version / Model
- MOL4250
- Catalog Number
- MOL4250
- Company Name
- DIASORIN MOLECULAR LLC
- Labeler DUNS
- 080271715
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-23
- Public Version
- 2
- Public Version Date
- 2023-12-18
- Public Version Status
- Update
- Public Device Record Key
- c0ef7b1e-4ee5-4238-90ff-7d286c432ff9
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QOF | Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents | Microbiology | 866.3981 | 2 |
| OOI | Real Time Nucleic Acid Amplification System | Clinical Chemistry | 862.2570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47922 | Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple virus genera associated with respiratory diseases in a clinical specimen, using a nucleic acid technique (NAT). Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses, rhinoviruses and/or adenoviruses. This test is commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 20816101027143 | GS1 |
Customer Contacts
- Phone
- 5622406500
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K220963 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -30 – -10 Degrees Celsius