FDA UDI
Not in Commercial Distribution
🇺🇸 United States
PRODESSE
DI: 15420045506398
·
Model: PROPARAFLU+ KIT, 100 REACTIONS
·
Hologic, Inc.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PRODESSE
- Primary DI
- 15420045506398
- Version / Model
- PROPARAFLU+ KIT, 100 REACTIONS
- Catalog Number
- 303677
- Company Name
- Hologic, Inc.
- Labeler DUNS
- 050579217
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-04-15
- Public Version
- 7
- Public Version Date
- 2023-12-18
- Public Version Status
- Update
- Public Device Record Key
- 4c8c2d9d-c2fa-4a89-99a6-ddf88dfe368c
- Distribution End Date
- 2019-06-30
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| OOU | Parainfluenza multiplex nucleic acid assay | Microbiology | 866.3980 | 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 | 15420045506398 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K132238 | 000 |