ClearanceBrief
Product code QKP ยท Class N

Coronavirus Antigen Detection Test System.

0510(k)s in 12 months (0 all time)
0recalls in 12 months (47 all time)
0recalls that name a 510(k)
Get daily alerts for QKPSample briefCSV

Top companies in QKP

Company510(k)sRecalls
Beckman Coulter Inc.05
CELLTRION USA INC05
INNOVA MEDICAL GROUP, INC.03
LumiraDx03
Ortho-Clinical Diagnostics, INc.03
Guangzhou Pluslife Biotech Co., Ltd.02
Lusys Laboratories, Inc.02
SD Biosensor, Inc.02
Siemens Healthcare Diagnostics, Inc02
Woodside Acquisitions Inc.02
DateFirm and productCodeLinked 510(k)
Jun 13, 2025Guangzhou Pluslife Biotech Co., Ltd.
Brand Name: Pluslife SARS-CoV-2 Card Product Name: SARS-CoV-2 Nucleic Acid Testing Card Model/Catalog Number: RM1010202 Software Version: N/A Product Description: 1. Product Overview Product Name: SAR
Open, Classified
QKPNone listed
Jun 13, 2025Guangzhou Pluslife Biotech Co., Ltd.
Brand Name: MiniDock Product Name: Integrated Nucleic Acid Testing Device Model/Catalog Number: PM001 Software Version: N/A Product Description: 1. Product Overview 1.1 Product Name: Integrated Nuclei
Open, Classified
QKPNone listed
May 23, 2023SD Biosensor, Inc.
Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 99COV200L-EN02, UPC Code: 887473000207 (EAN-13: 08800111707728)
Open, Classified
QKPNone listed
Jan 27, 2023Universal Meditech Inc.
Products are labeled as: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) 20 TESTS/1 KIT Green and white box under the brand DiagnosUS, and, White box without brand name
Open, Classified
QKPNone listed
Jan 4, 2023Detect Headquarters
Detect Covid-19 Test Product/Model Number: 21205
Open, Classified
QKPNone listed
Oct 26, 2022LumiraDx
LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit Catalog #: L016080109002 (EUA) The LumiraDx SARS-CoV-2 Quality Controls are intended for liquid quality control testing performed on the Lu
Terminated
QKPNone listed
Oct 12, 2022LUMINOSTICS, INC dba CLIP HEALTH
Clip COVID Rapid Antigen Test Kit (25-pack), Catalog Number: MDL002
Open, Classified
QKPNone listed
Oct 8, 2022Jiangsu Well Biotech Co.,Ltd.
Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02
Open, Classified
QKPNone listed
Jun 15, 2022North American Diagnostics
SARS CoV 2 rapid antigen test kits packaged under the following brands: Oral Rapid Test, Oral Rapid Antigen Test, SML LDT Kits, SML Brand Finished Kits, SML Brand BT Test Kits, SML Brand BT Antigen Te
Open, Classified
QKPNone listed
Apr 27, 2022CELLTRION USA INC
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
Terminated
QKPNone listed
Apr 9, 2022Woodside Acquisitions Inc.
Joysbio SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test
Open, Classified
QKPNone listed
Apr 9, 2022Woodside Acquisitions Inc.
Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit; COVID 19 Test
Open, Classified
QKPNone listed
Apr 4, 2022USA Medical, LLC
Diagnostic Kit SARS-cCo V Antigen Rapid Test
Open, Classified
QKPNone listed
Mar 8, 2022CELLTRION USA INC
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
Open, Classified
QKPNone listed
Mar 4, 2022SML Distribution, LLC
Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test
Open, Classified
QKPNone listed
Mar 4, 2022WHPM Inc.
First SIGN SARS-CoV-2 Antigen Test
Terminated
QKPNone listed
Mar 2, 2022CELLTRION USA INC
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
Terminated
QKPNone listed
Mar 2, 2022CELLTRION USA INC
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
Terminated
QKPNone listed
Feb 9, 2022E25Bio, Inc.
E25Bio COVID-19 Direct Antigen Rapid Test ; E25Bio COVID-19 DART Kit
Terminated
QKPNone listed
Jan 31, 2022SD Biosensor, Inc.
STANDARD Q COVID-19 Ag Home Test STANDARD Q COVID-19 Ag Home Test is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigen present in human nasal sample
Open, Classified
QKPNone listed
Jan 13, 2022Lusys Laboratories, Inc.
Luscient Diagnostics 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Nasal Swab Test)
Open, Classified
QKPNone listed
Jan 13, 2022Lusys Laboratories, Inc.
LuSys 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Saliva Test)
Open, Classified
QKPNone listed
Jan 9, 2022Acon Biotech (Hangzhou) Co., Ltd.
Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), CE marked
Open, Classified
QKPNone listed
Dec 22, 2021Empowered Diagnostics LLC
CovClear COVID-19 Rapid Antigen Test, ATG 900-031
Completed
QKPNone listed
Dec 1, 2021CELLTRION USA INC
Celltrion DiaTrust COVID-19 Ag Rapid Test, REF CT-P60 D-2 01. Contains 25 disposable test tubes with extraction buffer, 25 filter caps, 25 sterilized swabs per box.
Terminated
QKPNone listed
Nov 4, 2021Migo Trading LLC
FLOWFLEX SARS-COV-2 Antigen Rapid Test (Self-Testing), 1 Test
Open, Classified
QKPNone listed
Oct 1, 2021ELLUME LTD
Ellume COVID-19 Home Test
Open, Classified
QKPNone listed
Sep 22, 2021Siemens Healthcare Diagnostics, Inc
ADVIA Centaur SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207866
Terminated
QKPNone listed
Sep 22, 2021Siemens Healthcare Diagnostics, Inc
Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207861
Terminated
QKPNone listed
Jul 27, 2021Versea Diagnostics LLC
CareStart COVID-19 Antigen Rapid Diagnostic Test for the detection of SARS-CoV-2 Antigen Qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal or anterior nasal
Terminated
QKPNone listed
Jul 1, 2021Beckman Coulter Inc.
ACCESS SARS-CoV-2 ANTIGEN EXTRACTION SOLUTION, CONTENTS: 6 x 6.0 mL EXTRACTION SOLN, IVD, Rx Only, UDI: (01)15099590743017
Terminated
QKPNone listed
Jul 1, 2021Beckman Coulter Inc.
ACCESS SARS-CoV-2 ANTIGEN QC, REF: C68670, CONTENTS: 3 X 6.0 mL QC1, 3 x 6.0 mL QC2, 1 QC VALUE CARD, IVD, Rx Only, UDI: (01)15099590742737;
Terminated
QKPNone listed
Jul 1, 2021Beckman Coulter Inc.
Access SARS-CoV-2 Antigen Calibrators, Catalog, REF: C68669, Contents: 1x2.5 mL C0, 1x2.5mL C1, 1x CAL CARD, UDI: (01)15099590742720;
Terminated
QKPNone listed
Jul 1, 2021Beckman Coulter Inc.
ACCESS SARS-CoV-2 Antigen , REF: C68668, IVD, Rx only, UDI: (01) 15099590742713;
Terminated
QKPNone listed
May 3, 2021Ortho-Clinical Diagnostics, INc.
VITROS CoV2 Ag calibrator (Product Code 6199950) - Product Usage: is a chemiluminescent immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in nasopharyngea
Terminated
QKPNone listed
Apr 26, 2021LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD
Leccurate SARS-CoV-2, Antigen Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. for the qualitative detection of antigen SARS-CoV-2 in clinical samples (nasal swab).
Completed
QKPNone listed
Apr 14, 2021Beckman Coulter Inc.
Access SARS-CoV-2 Antigen, REF C68668, UDI: (01)15099590742713, 3.30 mL/R1a, 4.70 mL/R1b, 4.20 mL/R1c, 3.10 mL, R1d, 3.10 mL, R1e
Terminated
QKPNone listed
Apr 9, 2021INNOVA MEDICAL GROUP, INC.
COVID-19 Self-Test Kit *** INNOVA *** 3T
Open, Classified
QKPNone listed
Apr 9, 2021INNOVA MEDICAL GROUP, INC.
For In Vitro Diagnostic Use Only *** 25T 888 SARS-CoV-2 Antigen *** SARS-CoV-2 Antigen Rapid Qualitative Test *** REF BT1309
Open, Classified
QKPNone listed
Apr 9, 2021INNOVA MEDICAL GROUP, INC.
COVID-19 Self-Test Kit *** INNOVA *** 7T
Open, Classified
QKPNone listed
Mar 1, 2021Cellex
Cellex qSARS-Cov-2 Antigen Rapid Test, 25 tests/box, submitted as EUA202955 "declined to issue"
Open, Classified
QKPNone listed
Feb 17, 2021LumiraDx
LumiraDx SARS-CoV-2 Ag Test Strip Kit US EUA (48 Tests / EN). LumiraDx Severe Acute Respiratory Syndrome (SARS) CoV-2 Antigen (Ag) Test Strips, Catalog #:L016000109048. Part of the LumiraDx Platfo
Terminated
QKPNone listed
Feb 12, 2021Ortho-Clinical Diagnostics, Inc.
VITROS SARS-CoV-2 Antigen Reagent Pack - The VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack when used in combination with the VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Cali
Terminated
QKPNone listed
Feb 12, 2021Ortho-Clinical Diagnostics, Inc.
VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent- In Vitro Diagnostic. The VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack when used in combination with the VITROS Immunodi
Terminated
QKPNone listed
Feb 3, 2021LumiraDx
Coronavirus antigen detection test system - Product Usage: intended for the qualitative detection of the nucleocapsid protein antigen to SARS-CoV-2 directly from nasal swab samples collected from indi
Terminated
QKPNone listed
Jan 15, 2021Qiagen Sciences LLC
SARS-CoV-2 Antigen Test
Terminated
QKPNone listed
Sep 17, 2020Quidel Corporation
Sofia SARS Antigen FIA Package Insert The Sofia SARS Antigen FIA is a lateral flow immunofluorescent sandwich assay that is used with the Sofia and Sofia 2 instrument intended for the qualitative de
Terminated
QKPNone listed

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.