Identity
- Trade Name
- BioFire® COVID-19 Test 2 FDA UDI
- Generic Name
- SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- BioFire® COVID-19 Test 2 - IVD reagent kit containing 30 tests FDA UDI
- Model / Reference
- DFA2-ASY-0016 FDA UDI
- Description
- BioFire® COVID-19 Test 2 - IVD reagent kit containing 30 tests FDA UDI
Identifiers
- Catalog Number
- DFA2-ASY-0016 FDA UDI
- Primary DI / UDI-DI
- 00851458005235 FDA UDI
- FDA Product Code
- QQX FDA UDI
- GMDN Term
- SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3981 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: SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)
BioFire® COVID-19 Test 2 by BioFire Defense, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT).
- RealTime — Abbott Molecular · N
- ViroKey® SARS-CoV-2 RT-PCR Test v2.0 (8x48) — VELA OPERATIONS SINGAPORE PTE. LTD.
- cobas liat SARS-CoV-2 v2 nucleic acid test — Roche Molecular Systems, Inc. · Class II
- Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Assay Kit — LIFE TECHNOLOGIES LIMITED · Class II
- Simplexa COVID-19 Positive Control GEN II Pack — DiaSorin Molecular LLC · Class II
- Accula SARS-CoV-2 Test — MESA BIOTECH, INC. · N
- Lyra — DIAGNOSTIC HYBRIDS, INC. · N
- EURORealTime SARS-CoV-2 — EUROIMMUN Medizinische Labordiagnostika AG · N
Cleared under the same submission
K211079 also covers:
K221460 also covers:
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
- BioFire Defense, LLC
Sources (1)
- FDA UDI bf8b7ffb-22f3-4cfc-8132-b5a0ca18a387 36 fields · synced Jun 6, 2026