FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Light Diagnostics™ SimulFluor® Flu A/Flu B Immunofluorescence Assay
DI: 04053252367588
·
Model: 3121
·
EMD Millipore Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Light Diagnostics™ SimulFluor® Flu A/Flu B Immunofluorescence Assay
- Primary DI
- 04053252367588
- Version / Model
- 3121
- Catalog Number
- 3121
- Company Name
- EMD Millipore Corporation
- Labeler DUNS
- 829517072
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-28
- Public Version
- 3
- Public Version Date
- 2023-12-18
- Public Version Status
- Update
- Public Device Record Key
- 9c3d1120-1694-4f92-87d2-466a0370ee7c
- Distribution End Date
- 2023-04-30
Device Description
SimulFluor® Flu A/Flu B Immunofluorescence Assay
Device Characteristics
- Single Use
- No
- 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
- 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 |
|---|---|---|---|---|
| GNW | Antisera, Cf, Influenza Virus A, B, C | Microbiology | 866.3330 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48257 | Multiple-genus respiratory virus antigen IVD, kit, enzyme immunoassay (EIA) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from multiple virus genera associated with respiratory disease in a clinical specimen, using an enzyme immunoassay (EIA) method. 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 | 04053252367588 | GS1 |
Customer Contacts
- Phone
- 1 (951) 676-8080
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K974302 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius