FDA UDI
In Commercial Distribution
🇺🇸 United States
Simplexa COVID-19 / Flu A/B & RSV Positive Control Pack
DI: 20816101027365
·
Model: MOL4460
·
DIASORIN MOLECULAR LLC
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Simplexa COVID-19 / Flu A/B & RSV Positive Control Pack
- Primary DI
- 20816101027365
- Version / Model
- MOL4460
- Catalog Number
- MOL4460
- Company Name
- DIASORIN MOLECULAR LLC
- Labeler DUNS
- 080271715
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-01-14
- Public Version
- 1
- Public Version Date
- 2026-01-22
- Public Version Status
- New
- Public Device Record Key
- 231e39dd-47cf-4470-9d66-ac82658b8853
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 |
|---|---|---|---|---|
| 47920 | Multiple-genus respiratory virus nucleic acid IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple virus genera associated with respiratory disease in a clinical specimen. Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses, rhinoviruses and/or adenoviruses. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 20816101027365 | GS1 |
Customer Contacts
- Phone
- 15622406500
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -30 – -10 Degrees Celsius