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)
Top companies in QKP
| Company | 510(k)s | Recalls |
|---|---|---|
| Beckman Coulter Inc. | 0 | 5 |
| CELLTRION USA INC | 0 | 5 |
| INNOVA MEDICAL GROUP, INC. | 0 | 3 |
| LumiraDx | 0 | 3 |
| Ortho-Clinical Diagnostics, INc. | 0 | 3 |
| Guangzhou Pluslife Biotech Co., Ltd. | 0 | 2 |
| Lusys Laboratories, Inc. | 0 | 2 |
| SD Biosensor, Inc. | 0 | 2 |
| Siemens Healthcare Diagnostics, Inc | 0 | 2 |
| Woodside Acquisitions Inc. | 0 | 2 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 13, 2025 | Guangzhou 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 |
QKP | None listed |
| Jun 13, 2025 | Guangzhou 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 |
QKP | None listed |
| May 23, 2023 | SD 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 |
QKP | None listed |
| Jan 27, 2023 | Universal 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 |
QKP | None listed |
| Jan 4, 2023 | Detect Headquarters Detect Covid-19 Test
Product/Model Number: 21205 Open, Classified |
QKP | None listed |
| Oct 26, 2022 | LumiraDx 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 |
QKP | None listed |
| Oct 12, 2022 | LUMINOSTICS, INC dba CLIP HEALTH Clip COVID Rapid Antigen Test Kit (25-pack), Catalog Number: MDL002 Open, Classified |
QKP | None listed |
| Oct 8, 2022 | Jiangsu Well Biotech Co.,Ltd. Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02 Open, Classified |
QKP | None listed |
| Jun 15, 2022 | North 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 |
QKP | None listed |
| Apr 27, 2022 | CELLTRION USA INC Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02 Terminated |
QKP | None listed |
| Apr 9, 2022 | Woodside Acquisitions Inc. Joysbio SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test Open, Classified |
QKP | None listed |
| Apr 9, 2022 | Woodside Acquisitions Inc. Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit; COVID 19 Test Open, Classified |
QKP | None listed |
| Apr 4, 2022 | USA Medical, LLC Diagnostic Kit SARS-cCo V Antigen Rapid Test Open, Classified |
QKP | None listed |
| Mar 8, 2022 | CELLTRION USA INC Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02 Open, Classified |
QKP | None listed |
| Mar 4, 2022 | SML Distribution, LLC Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test Open, Classified |
QKP | None listed |
| Mar 4, 2022 | WHPM Inc. First SIGN SARS-CoV-2 Antigen Test Terminated |
QKP | None listed |
| Mar 2, 2022 | CELLTRION USA INC Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02 Terminated |
QKP | None listed |
| Mar 2, 2022 | CELLTRION USA INC Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02 Terminated |
QKP | None listed |
| Feb 9, 2022 | E25Bio, Inc. E25Bio COVID-19 Direct Antigen Rapid Test ; E25Bio COVID-19 DART Kit Terminated |
QKP | None listed |
| Jan 31, 2022 | SD 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 |
QKP | None listed |
| Jan 13, 2022 | Lusys Laboratories, Inc. Luscient Diagnostics 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Nasal Swab Test) Open, Classified |
QKP | None listed |
| Jan 13, 2022 | Lusys Laboratories, Inc. LuSys 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Saliva Test) Open, Classified |
QKP | None listed |
| Jan 9, 2022 | Acon Biotech (Hangzhou) Co., Ltd. Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), CE marked Open, Classified |
QKP | None listed |
| Dec 22, 2021 | Empowered Diagnostics LLC CovClear COVID-19 Rapid Antigen Test, ATG 900-031 Completed |
QKP | None listed |
| Dec 1, 2021 | CELLTRION 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 |
QKP | None listed |
| Nov 4, 2021 | Migo Trading LLC FLOWFLEX SARS-COV-2 Antigen Rapid Test (Self-Testing), 1 Test Open, Classified |
QKP | None listed |
| Oct 1, 2021 | ELLUME LTD Ellume COVID-19 Home Test Open, Classified |
QKP | None listed |
| Sep 22, 2021 | Siemens Healthcare Diagnostics, Inc ADVIA Centaur SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207866 Terminated |
QKP | None listed |
| Sep 22, 2021 | Siemens Healthcare Diagnostics, Inc Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207861 Terminated |
QKP | None listed |
| Jul 27, 2021 | Versea 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 |
QKP | None listed |
| Jul 1, 2021 | Beckman Coulter Inc. ACCESS SARS-CoV-2 ANTIGEN EXTRACTION SOLUTION, CONTENTS: 6 x 6.0 mL EXTRACTION SOLN, IVD, Rx Only, UDI: (01)15099590743017 Terminated |
QKP | None listed |
| Jul 1, 2021 | Beckman 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 |
QKP | None listed |
| Jul 1, 2021 | Beckman 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 |
QKP | None listed |
| Jul 1, 2021 | Beckman Coulter Inc. ACCESS SARS-CoV-2 Antigen , REF: C68668, IVD, Rx only, UDI: (01) 15099590742713; Terminated |
QKP | None listed |
| May 3, 2021 | Ortho-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 |
QKP | None listed |
| Apr 26, 2021 | LEPU 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 |
QKP | None listed |
| Apr 14, 2021 | Beckman 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 |
QKP | None listed |
| Apr 9, 2021 | INNOVA MEDICAL GROUP, INC. COVID-19 Self-Test Kit *** INNOVA *** 3T Open, Classified |
QKP | None listed |
| Apr 9, 2021 | INNOVA 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 |
QKP | None listed |
| Apr 9, 2021 | INNOVA MEDICAL GROUP, INC. COVID-19 Self-Test Kit *** INNOVA *** 7T Open, Classified |
QKP | None listed |
| Mar 1, 2021 | Cellex Cellex qSARS-Cov-2 Antigen Rapid Test, 25 tests/box, submitted as EUA202955 "declined to issue" Open, Classified |
QKP | None listed |
| Feb 17, 2021 | LumiraDx 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 |
QKP | None listed |
| Feb 12, 2021 | Ortho-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 |
QKP | None listed |
| Feb 12, 2021 | Ortho-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 |
QKP | None listed |
| Feb 3, 2021 | LumiraDx 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 |
QKP | None listed |
| Jan 15, 2021 | Qiagen Sciences LLC SARS-CoV-2 Antigen Test Terminated |
QKP | None listed |
| Sep 17, 2020 | Quidel 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 |
QKP | None listed |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.