FDA UDI
In Commercial Distribution
🇺🇸 United States
statID Pro COVID-19/Flu External Controls
DI: 00840733101557
·
Model: 783010
·
MERIDIAN BIOSCIENCE, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- statID Pro COVID-19/Flu External Controls
- Primary DI
- 00840733101557
- Version / Model
- 783010
- Company Name
- MERIDIAN BIOSCIENCE, INC.
- Labeler DUNS
- 092815364
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-04-10
- Public Version
- 1
- Public Version Date
- 2026-04-20
- Public Version Status
- New
- Public Device Record Key
- 7c6f1125-f650-487a-bef6-bbe99a0b45cb
Device Description
The External Control - statID Pro COVID-19/Flu A&B is ready to use external control kit for use with the statID Pro COVID-19/Flu A&B. This kit is designed to verify propr test procedure and performance of the statID Pro-COVID-19/Flu A&B.
Device Characteristics
- Single Use
- Yes
- 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 |
|---|---|---|---|---|
| SCA | Multi-Analyte Respiratory Virus Antigen Detection Test | Microbiology | 866.3987 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48247 | Multiple-genus respiratory virus antigen 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 antigens from multiple virus genera associated with respiratory diseases 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 | 00840733101557 | GS1 |
Customer Contacts
- Phone
- 800-343-3858
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN240029 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 2 – 30 Degrees Celsius