FDA UDI
In Commercial Distribution
🇺🇸 United States
Lyra
DI: 30014613311027
·
Model: Direct HSV 1+2/VZV Assay
·
QUIDEL CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Lyra
- Primary DI
- 30014613311027
- Version / Model
- Direct HSV 1+2/VZV Assay
- Catalog Number
- M102
- Company Name
- QUIDEL CORPORATION
- Labeler DUNS
- 079509836
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-15
- Public Version
- 4
- Public Version Date
- 2023-06-29
- Public Version Status
- Update
- Public Device Record Key
- 13fbb4c1-d880-453e-9394-f3a81150e944
Device Description
Lyra Direct HSV 1+2/VZV Assay
Device Characteristics
- Single Use
- Yes
- 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 |
|---|---|---|---|---|
| PGI | Herpes virus (VZV, HSV1, HSV2), DNA Detection Assay for cutaneous and mucocutaneous lesion samples | Microbiology | 866.3309 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61334 | Multiple Human herpesvirus 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 one or multiple human herpesviruses in a clinical specimen, using a nucleic acid technique (NAT). Viruses detected may include (but not limited to) herpes simplex virus 1 (HSV1), herpes simplex virus 2 (HSV2) and/or varicella-zoster virus (VZV). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 30014613311027 | GS1 |
Customer Contacts
- Phone
- +1(858)552-1100
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius