FDA.reportPublic FDA data

CHEMBIO DIAGNOSTIC SYSTEMS, INC.

Matched from indexed company URL: Chembio Diagnostic Systems

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
24319802431980CHEMBIO DIAGNOSTIC SYSTEMS, INC.1N2026-01-013661 HORSEBLOCK RD. MEDFORD NY US 11763
30265658543026565854Chembio Diagnostic Systems1N2026-01-011560 Fifth Avenue Bay Shore NY US 11706
30154175773015417577CHEMBIO DIAGNOSTIC SYSTEMS, INC.1N2020-04-25555 Wireless Blvd -- Hauppauge NY US 11788

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
372591631896261K981913PREVUE(TM) BORRELIA BURGDORFERI ANTIBODY DETECTION ASSAYLSR1999-02-12
372591047589688K841272SICKLE-STAT HEMOGLOBIN S SCREEN KITGHM1984-04-13
3140321223729752K201256Procise CRP, ProciseDx Analyzer, ProciseDx Calibration CartridgeDCK2022-11-04
372591223729752K201256Procise CRP, ProciseDx Analyzer, ProciseDx Calibration CartridgeDCK2022-11-04
3140321775969049K200506DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro ReaderQFO2020-06-03
372591775969049K200506DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro ReaderQFO2020-06-03
3140321520495084DEN220023Procise ADLQYD2023-09-29
372591520495084DEN220023Procise ADLQYD2023-09-29
3140321874491930DEN210056Procise IFXQXT2023-09-29
372591874491930DEN210056Procise IFXQXT2023-09-29
372591612122346BP180191
3140321612122346BP180191
3140322071783988BP120032
2282482071783988BP120032
372592071783988BP120032
372591644858497BP050010
3140321644858497BP050010
2282481644858497BP050010
3140321935880440BP050009
2282481935880440BP050009
372591935880440BP050009
372591355693512
372591367097767
372591412910397
372591599258548
372591164800073
3140321164800073
372591196863456
3140321196863456
372591203501902
3140321203501902
3140321355693512
3140321417634285
372591417634285
3140321430810002
372591430810002
3140321453912107
372591453912107
3140321556428107
372591556428107
3140321595865827
372591595865827
3140321599258548
3140321809922621
372591809922621

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
QYD22023-09-29
QXT22023-09-29
DCK22022-11-04
QFO22020-06-03
LSR11999-02-12
GHM11984-04-13

PMN#

GUDID#

ProciseDx Calibration Cartridge - The ProciseDx Calibration Cartridge is an accessory with quantitative assigned values to the ProciseDx Analyzer and is used to confirm that the instrument is operating within specified limits. The calibration cartridge does not contact biological specimens and is not used for diagnostic testing. The intended users are clinical laboratory professionals responsible for completing a periodic calibration check of the ProciseDx Analyzer.

Chembio Diagnostic Systems Inc.

2024-08-06

Procise ADL - The Procise ADL assay is a time-resolved fluorescence energy transfer immunoassay for the quantitative determination of adalimumab (ADL) levels in venous serum in patients undergoing adalimumab therapy, using the ProciseDx Analyzer.Measurements obtained by this assay can be used to detect adalimumab as an aid in the management of patients with inflammatory bowel diseases (IBD): Crohn's disease and ulcerative colitis being treated with adalimumab. The test is intended for use in a clinical laboratory.

Chembio Diagnostic Systems Inc.

2024-08-16

Procise IFX - The Procise IFX assay is a time-resolved fluorescence energy transfer immunoassay for the quantitative determination of infliximab levels in venous serum in patients undergoing infliximab therapy, using the ProciseDx Analyzer.Measurements obtained by this assay can be used to detect infliximab as an aid in the management of patients with inflammatory bowel diseases (IBD): Crohn's disease and ulcerative colitis being treated with infliximab. The test is intended for use in a clinical laboratory.

Chembio Diagnostic Systems Inc.

2024-08-16

DPP HIV-Syphilis - The DPP® HIV-Syphilis is a single-use rapid, qualitative, multiplex, immunoassay for the detection of antibodies to Human Immunodeficiency Virus Types 1 and 2 (HIV-1/2), and/or Treponema pallidum bacteria (the causative agent of syphilis) in fingerstick whole blood, potassium-EDTA venous whole blood or potassium-EDTA plasma specimens. The test is intended to be used with the DPP Micro Reader. The test is intended for use by trained professionals in point of care and laboratory settings to aid in the diagnosis of HIV and syphilis infection.

Chembio Diagnostic Systems Inc.

2020-12-29

DPP Zika IgM Micro Reader - The DPP® Micro Reader for use with the DPP Zika IgM Assay System is a reflectance reader configured to read exclusive results of the DPP Zika IgM test cartridge, through the application of an RFID tag applied to one side of the reader, which carries the DPP Zika test configuration. Once configured, the reader measures the intensity of the control and analyte lines on the test device, and shows the test results on the LCD display. The DPP Micro Reader minimizes human errors due to subjective visual interpretation; therefore, the operator cannot visually interpret the results of DPP Assay Devices made to be read with a DPP Micro Reader; they must be read exclusively with the DPP Micro Reader.

Chembio Diagnostic Systems Inc.

2021-10-19

DPP Zika IgM System - The DPP Zika IgM System is intended for the presumptive qualitative detection of Zika virus IgM antibodies in human serum (plain or separation gel), potassium-EDTA plasma, potassium EDTA venous whole blood, or fingerstick whole blood specimens, collected from individuals meeting the CDC Zika virus clinical criteria (e.g., a history of clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiological criteria for which Zika virus testing may be indicated).

Chembio Diagnostic Systems Inc.

2020-08-06

Chembio HIV Reactive/Nonreactive Controls - The Chembio HIV Reactive/Nonreactive Controls are quality control reagents for use with the Chembio HIV 1/2 STAT-PAK® Assay only. Chembio HIV Reactive/Nonreactive Controls are human, plasma-based reagents. The Controls are specifically formulated and manufactured to ensure performance of the test, and are used to verify the user’s ability to properly perform the test and interpret the results. Each HIV Rapid Test Control Pack contains a Product Insert and three Vials (one HIV 1 Reactive Control, one HIV 2 Reactive Control and one Nonreactive Control).One Vial containing 0.25 mL of heat inactivated human plasma positive for antibodies to HIV-1, diluted in normal human plasma. Negative for Hepatitis B surface antigen, Hepatitis C antibody and HTLV I/II antibodies.One Vial containing 0.25 mL of heat inactivated human plasma positive for antibodies to HIV-2, diluted in normal human plasma. Negative for Hepatitis B surface antigen, Hepatitis C antibody and HTLV I/II antibodies.One Vial containing 0.25 mL of normal human plasma negative for antibodies to HIV-1 and HIV-2. Negative for Hepatitis B surface antigen, Hepatitis C antibody and HTLV I/II antibodies.

Chembio Diagnostic Systems Inc.

2014-09-01

Chembio SURE CHECK HIV 1/2 Assay - The Chembio SURE CHECK® HIV 1/2 Assay is a single-use immunochromatographic test for the detection of antibodies to Human Immunodeficiency Virus Types 1 (HIV-1) and Type 2 (HIV-2) in fingerstick whole blood, venous whole blood, and serum or plasma specimens. The Chembio SURE CHECK® HIV 1/2 Assay is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1 and HIV-2. This test is suitable for use in multi-test algorithms designed for the statistical validation of rapid HIV test results. When multiple rapid HIV tests are available, this test should be used in appropriate multi-test algorithms. Each kit contains 25 individually pouched tests each containing 1 Sampler with a Test Strip inside, 1 Buffer Vial attached to the Sampler (~350μL), 1 Sterile Safety Lancet, 1 Bandage, 1 Desiccant Packet; 25 Disposable Test Stands; 1 Product Insert; 25 Copies of Subject Information Notice.

Chembio Diagnostic Systems Inc.

2016-06-01

Chembio HIV 1/2 Stat-Pak Assay - The Chembio HIV 1/2 STAT-PAK® Assay is a single-use immunochromatographic test for the detection of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and Type 2 (HIV-2) in fingerstick whole blood, venous whole blood, serum or plasma specimens. The Chembio HIV 1/2 STAT-PAK® assay is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1 and HIV-2. This test is suitable for use in multi-test algorithms designed for the statistical validation of rapid HIV test results. When multiple rapid HIV tests are available, this test should be used in appropriate multi-test algorithms. Each kit contains 20 individually pouched tests, 1 bottle of HIV Running Buffer, 20 Disposable Loops, 1 Product Insert, and 20 Copies of Subject Information Notice.

Chembio Diagnostic Systems Inc.

2014-09-01

Chembio DPP HIV 1/2 Rapid Test Control Pack - The Chembio HIV Reactive/Nonreactive Controls are quality control reagents for use with the Chembio DPP HIV 1/2 Assay only. Chembio HIV Reactive/Nonreactive Controls are human, plasma-based reagents. The Controls are specifically formulated and manufactured to ensure performance of the test, and are used to verify the user’s ability to properly perform the test and interpret the results. Each HIV Rapid Test Control Pack contains a Product Insert and three Vials (one HIV 1 Reactive Control, one HIV 2 Reactive Control and one Nonreactive Control) as described. One Vial containing 0.5mL of heat inactivated human plasma positive for antibodies to HIV-1, diluted in normal human plasma. Negative for Hepatitis B surface antigen, Hepatitis C antibody and HTLV I/II antibodies.One Vial containing 0.5mL of heat inactivated human plasma positive for antibodies to HIV-2, diluted in normal human plasma. Negative for Hepatitis B surface antigen, Hepatitis C antibody and HTLV I/II antibodies. One Vial containing 0.5mL of normal human plasma negative for antibodies to HIV-1 and HIV-2. Negative for Hepatitis B surface antigen, Hepatitis C antibody and HTLV I/II antibodies.

Chembio Diagnostic Systems Inc.

2014-09-01

Clearview HIV Reactive/Nonreactive Controls - The Clearview® HIV Reactive/Nonreactive Controls are quality control reagents for use with the Clearview® COMPLETE HIV 1/2 Assay only. Clearview® HIV Reactive/Nonreactive Controls are human, plasma-based reagents. The Controls are specifically formulated and manufactured to ensure performance of the test, and are used to verify the user’s ability to properly perform the test and interpret the results. Each HIV Rapid Test Control Pack contains a Product Insert and three Vials (one HIV 1 Reactive Control, one HIV 2 Reactive Control and one Nonreactive Control).One Vial containing 0.25 mL of heat inactivated human plasma positive for antibodies to HIV-1, diluted in normal human plasma. Negative for Hepatitis B surface antigen, Hepatitis C antibody and HTLV I/II antibodies.One Vial containing 0.25 mL of heat inactivated human plasma positive for antibodies to HIV-2, diluted in normal human plasma. Negative for Hepatitis B surface antigen, Hepatitis C antibody and HTLV I/II antibodies.One Vial containing 0.25 mL of normal human plasma negative for antibodies to HIV-1 and HIV-2. Negative for Hepatitis B surface antigen, Hepatitis C antibody and HTLV I/II antibodies.

Chembio Diagnostic Systems Inc.

2014-09-01

Clearview Complete HIV 1/2 - The Clearview® COMPLETE HIV 1/2 assay is a single-use immunochromatographic test for the detection of antibodies to Human Immunodeficiency Virus Types 1 (HIV-1) and Type 2 (HIV-2) in fingerstick whole blood, venous whole blood, and serum or plasma specimens. The Clearview® COMPLETE HIV 1/2 assay is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1 and HIV-2. This test is suitable for use in multi-test algorithms designed for the statistical validation of rapid HIV test results. When multiple rapid HIV tests are available, this test should be used in appropriate multi-test algorithms. Each kit contains 25 individually pouched tests, 25 Disposable Test Stands, 1 Product Insert, and 25 Copies of Subject Information Notice.

Chembio Diagnostic Systems Inc.

2014-09-01

Chembio DPP HIV 1/2 Assay - The Chembio DPP® HIV 1/2 Assay is a single-use immunochromatographic test for the detection of antibodies to Human Immunodeficiency Virus Types 1 and 2 (HIV-1/2) in oral fluid, fingerstick whole blood, venous whole blood, serum, or plasma samples. The Chembio DPP HIV 1/2 Assay is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1 and HIV-2. This test is suitable for use in multi-test algorithms designed for the statistical validation of rapid HIV test results. When multiple rapid HIV tests are available, this test should be used in appropriate multi-test algorithms. Each kit contains 20 individually pouched tests, 1 bottle of DPP HIV Running Buffer, 20 Sampletainer Bottles, 20 Oral Fluid Swabs, 20 Disposable Loops, 1 Product Insert, and 20 Copies of Subject Information Notice.

Chembio Diagnostic Systems Inc.

2014-09-01