FDA UDI
Not in Commercial Distribution
🇺🇸 United States
FLU/RSV Positive Control
DI: 00840733101977
·
Model: 751110
·
MERIDIAN BIOSCIENCE, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- FLU/RSV Positive Control
- Primary DI
- 00840733101977
- Version / Model
- 751110
- Catalog Number
- 751110
- Company Name
- MERIDIAN BIOSCIENCE, INC.
- Labeler DUNS
- 092815364
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-11-17
- Public Version
- 2
- Public Version Date
- 2021-06-21
- Public Version Status
- Update
- Public Device Record Key
- db9fefcd-9c8a-4a2d-9bc9-a746f737af0d
- Distribution End Date
- 2021-05-13
Device Description
FLU/RSV Positive Control is an external control reagent to be used with TRU FLU and TRU RSV Test Kits as part of a routine quality control program
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 |
|---|---|---|---|---|
| GQG | Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus | Microbiology | 866.3480 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48264 | Influenza virus/respiratory syncytial virus (RSV) 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 influenza viruses (e.g., influenza A, influenza B) and respiratory syncytial virus (RSV) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840733101977 | GS1 |
Customer Contacts
- Phone
- 1-800-343-3858
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K071101 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius