Light Diagnostics™ Respiratory Panel DFA Kit
- Primary DI
- 04053252362064
- Brand
- Light Diagnostics™ Respiratory Panel DFA Kit
- Company
- EMD Millipore Corporation
- Model
- 3110
- Catalog number
- 3110
- Device description
- Respiratory Panel DFA Kit
- Published
- 2022-11-28
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Related Records
Contact Domains
merckgroup.comProduct Codes
| Code | Name |
|---|---|
| GNY | Antisera, Fluorescent, Adenovirus 1-33 |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| GNY | Antisera, Fluorescent, Adenovirus 1-33 | Microbiology | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 04053252362064 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 04053252362064 | 04053252362064 | 4053252362064 |
GMDN Terms
| Term | Definition |
|---|---|
| Multiple respiratory virus antigen IVD, kit, fluorescent immunoassay | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple antigens from viruses associated with respiratory diseases in a clinical specimen, using a fluorescent immunoassay method. Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses, rhinoviruses and/or adenoviruses. |
Storage And Handling
| Type | Low | High | Condition |
|---|---|---|---|
| Storage Environment Temperature | 2 Degrees Celsius | 8 Degrees Celsius |
Sterilization Methods
| Method |
|---|
Contacts
| Phone | |
|---|---|
| 1 (951) 676-8080 | R128863@merckgroup.com |
Regulatory Flags
- DUNS number
- 829517072
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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