Identity
- Trade Name
- QuickProfile™ 2019-nCoV IgG/IgM Antibody Test FDA UDI
- Generic Name
- SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- QuickProfile™ 2019-nCoV IgG/IgM Test Card is an immunochromatography based one step in vitro test. It is designed for the rapid qualitative determination of IgG and IgM antibodies to the 2019 novel coronavirus (2019-nCoV, SARS-CoV-2) in human serum, plasma, or whole blood. QuickProfile™ 2019-nCoV IgG/IgM Test Card is a supplemental rapid screening tool for symptomatic or asymptomatic carriers of the virus. FDA UDI
- Model / Reference
- 71108B FDA UDI
- Description
- QuickProfile™ 2019-nCoV IgG/IgM Test Card is an immunochromatography based one step in vitro test. It is designed for the rapid qualitative determination of IgG and IgM antibodies to the 2019 novel coronavirus (2019-nCoV, SARS-CoV-2) in human serum, plasma, or whole blood. QuickProfile™ 2019-nCoV IgG/IgM Test Card is a supplemental rapid screening tool for symptomatic or asymptomatic carriers of the virus. FDA UDI
Identifiers
- Catalog Number
- 71108B FDA UDI
- Primary DI / UDI-DI
- M90171108B0 FDA UDI
- FDA Product Code
- QKO FDA UDI
- GMDN Term
- SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- N 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
Dimensions & Sizes
- Size
- Length — 80 Millimeter FDA UDI
Category: SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical
QuickProfile™ 2019-nCoV IgG/IgM Antibody Test by LumiQuick Diagnostics, Inc. — Class N — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical.
- Fastep COVID-19 IgG/IgM Rapid Test Device — ASSURE TECH. (HANGZHOU) CO., LTD. · N
- Nano-CheckTM COVID-19 IgG/IgM Antibody Test — Nano-Ditech Corporation · N
- Rapid Response — BTNX Inc · N
- Lyher — Hangzhou Laihe Biotech Co., Ltd. · N
- ACON SARS-CoV-2 IgG/IgM Rapid Test — ACON Laboratories, Inc. · N
- CLIAWAIVED INC — CLIAWAIVED,INC.
- Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit — Biohit Healthcare (Hefei) Co., Ltd. · N
- CLIAWAIVED INC — CLIAWAIVED,INC.
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 N | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- LumiQuick Diagnostics, Inc.
Sources (1)
- FDA UDI dc5124d6-910c-4858-bdc7-72e9d2e11107 37 fields · synced Jun 9, 2026