Identity
- Trade Name
- Lyra FDA UDI
- Generic Name
- Multiple Beta-haemolytic Streptococcus serogroup nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- Lyra Direct Strep Assay FDA UDI
- Model / Reference
- Direct Strep Assay FDA UDI
- Description
- Lyra Direct Strep Assay FDA UDI
Identifiers
- Catalog Number
- M112 FDA UDI
- Primary DI / UDI-DI
- 30014613311126 FDA UDI
- FDA Product Code
- PGX FDA UDI
- GMDN Term
- Multiple Beta-haemolytic Streptococcus serogroup nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.2680 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple Beta-haemolytic Streptococcus serogroup nucleic acid IVD, kit, nucleic acid technique (NAT)
Lyra by Quidel Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Quidel Corp.
Sources (1)
- FDA UDI 9f26021f-6d00-472b-97f9-bcee5290cc93 36 fields · synced May 30, 2026