FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Respiratory Virus Panel Antigen Control Slide, 14 wells
DI: B110QRP63140
·
Model: QRP-6314
·
Bion Enterprises, Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Respiratory Virus Panel Antigen Control Slide, 14 wells
- Primary DI
- B110QRP63140
- Version / Model
- QRP-6314
- Catalog Number
- QRP-6314
- Company Name
- Bion Enterprises, Ltd.
- Labeler DUNS
- 024824641
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-12
- Public Version
- 6
- Public Version Date
- 2023-12-18
- Public Version Status
- Update
- Public Device Record Key
- 190edcd3-aea8-455e-b14d-0273c6e9687b
- Distribution End Date
- 2022-03-22
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- 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 |
|---|---|---|---|---|
| LJG | Quality Control Slides | Microbiology | 866.2660 | 1 |
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 | B110QRP63140 | HIBCC |
Customer Contacts
- Phone
- 847-544-5044
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K890616 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 8 Degrees Celsius