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    Chembio Diagnostic Systems Inc.

    Manufacturer
    🇺🇸 United States

    CHEMBIO DIAGNOSTIC SYSTEMS, INC.

    FDA registration
    CHEMBIO DIAGNOSTIC SYSTEMS, INC.·17 products·🇺🇸 United States

    ProciseDx Analyzer

    FDA UDI
    Chembio Diagnostic Systems Inc.·08100322943909·The ProciseDx Analyzer is intended for use with...

    ProciseDx Calibration Cartridge

    FDA UDI
    Chembio Diagnostic Systems Inc.·08100322954295·The ProciseDx Calibration Cartridge is an acces...

    Procise ADL

    FDA UDI
    Chembio Diagnostic Systems Inc.·08100322954301·The Procise ADL assay is a time-resolved fluore...

    DPP Zika IgM Micro Reader

    FDA UDI
    Chembio Diagnostic Systems Inc.·00607158000113·The DPP® Micro Reader for use with the DPP Zika...

    Chembio DPP HIV 1/2 Rapid Test Control Pack

    FDA UDI
    Chembio Diagnostic Systems Inc.·00607158000045·The Chembio HIV Reactive/Nonreactive Controls a...

    Clearview Complete HIV 1/2

    FDA UDI
    Chembio Diagnostic Systems Inc.·00607158000021·The Clearview® COMPLETE HIV 1/2 assay is a sing...

    Clearview HIV Reactive/Nonreactive Controls

    FDA UDI
    Chembio Diagnostic Systems Inc.·00607158000038·The Clearview® HIV Reactive/Nonreactive Control...

    DPP HIV-Syphilis

    FDA UDI
    Chembio Diagnostic Systems Inc.·00607158000083·The DPP® HIV-Syphilis is a single-use rapid, qu...

    Chembio HIV 1/2 Stat-Pak Assay

    FDA UDI
    Chembio Diagnostic Systems Inc.·00607158000052·The Chembio HIV 1/2 STAT-PAK® Assay is a single...

    Chembio HIV Reactive/Nonreactive Controls

    FDA UDI
    Chembio Diagnostic Systems Inc.·00607158000076·The Chembio HIV Reactive/Nonreactive Controls a...

    DPP Zika IgM System

    FDA UDI
    Chembio Diagnostic Systems Inc.·00607158000106·The DPP Zika IgM System is intended for the pre...

    Procise IFX

    FDA UDI
    Chembio Diagnostic Systems Inc.·08100322953854·The Procise IFX assay is a time-resolved fluore...

    Chembio DPP HIV 1/2 Assay

    FDA UDI
    Chembio Diagnostic Systems Inc.·00607158000007·The Chembio DPP® HIV 1/2 Assay is a single-use ...

    Chembio SURE CHECK HIV 1/2 Assay

    FDA UDI
    Chembio Diagnostic Systems Inc.·00607158000069·The Chembio SURE CHECK® HIV 1/2 Assay is a sing...

    H. PYLORI STAT - PAK

    FDA Adverse Event
    Other ·CHEMBIO DIAGNOSTIC SYSTEMS, INC.·Product code OWF·December 7, 2004

    OTC Pregnancy Tests. Name: Sure Check hCG Midstream Pregnancy Test --- Description: the Sure Check hCG Midstream Pregnancy test consists of a lateral flow membrane pad containing anti- hCG monoclonal antibody conjugated to colloidal gold contained in a plastic ''wand'' with an absorbent wick at one end. The device is packaged in a foil pouch with desiccant. Catalog numbers are solely used for ordering by the different distributors. This OTC product is shipped as either bulk packaged product or as private labeled material labeled as follows: (1) SURE CHECK™ ONE STEP Pregnancy Test --- 1 TEST; MANUFACTURED BY CHEMBIO DIAGNOSTIC SYSTEMS, INC. MEDFORD, NY 11763 MADE IN USA; UPC 6 07158 00110 3; Catalog # PT110SURE/12 (ordered by Dean Distribution, Fred's DC Memphis, Health Enterprises, Healthcare Products, Mason Distribution, Par-Med). (2) SURE CHECK™ ONE STEP Pregnancy Test --- 2 TESTS; MANUFACTURED BY CHEMBIO DIAGNOSTIC SYSTEMS, INC. MEDFORD, NY 11763 MADE IN USA; UPC 6 07158 00112 7; Catalog # PT112/24 (Fred's DC Memphis). (3) exact™ pregnancy test --- Product of U.S.A./Produit des E-U. Prepared for/Prepare pour LOBLAWS INC. Montreal H4N 3L4, Toronto M4T 2S8, Calgary T2E 7S9, Canada By/Par Chembio Diagnostics Systems, Medford, New York 11763 Imported by/Import par Le Group Neuco Image Inc., Montreal, Quebec H2P 2T4 Canada; UPC 0 60383 66207 3; Catalog # PT110-N4 (Neuco). (4) exact™ pregnancy test --- 2 tests; Product of U.S.A./Produit des E-U. Prepared for/Prepare pour LOBLAWS INC. Montreal H4N 3L4, Toronto M4T 2S8, Calgary T2E 7S9, Canada By/Par Chembio Diagnostics Systems, Medford, New York 11763 Imported by/Import par Le Group Neuco Image Inc., Montreal, Quebec H2P 2T4 Canada; UPC 0 60383 68179; Catalog # PT112-N4 (Neuco). (5) OUR BEST NOTRE MEILLEUR ONE STEP PREGNANCY TEST (TEST DE GROSSESSE EN UNE ETAPE) --- 1 TEST --- PRODUCT OF U.S.A./PRODUIT DES E.-U. IMPORTED FOR/IMPORTE POUR: SOBEYS MISSISSAUGA, ON L4V 1W2. Manufactured by/Fabriqu par: CHEMBIO DIAGNOSTIC SYSTEMS, INC.; UPC 0 61925 57608; Catalog # PT110-N7 (Neuco). (6) BODY BASICS™ Pregnancy Test (Test de grossesse) --- 1 Test --- PRODUCT OF U.S.A./PRODUIT DES E.-U.A. MANUFACTURED BY/FABRIQUE PAR: CHEMBIO DIAGNOSTIC SYSTEMS, INC. IMPORTED FOR/IMPORTE POUR: THE GREAT ATLANTIC & PACIFIC COMPANY OF CANADA LTD. TORONTO, CANADA M5W1A6; UPC 0 57627 71110 9; Catalog # PT110-N6/12 (Neuco) (7) Option+ TEST DE GROSSESSE UNE ETAPE/ONE STEP PREGNANCY TEST --- Produit des E.U/Product of U.S.A. Fabrique pour/Manufactured for: UNIPRIX Inc. Montreal H1S 3G7; UPC 7 71290 05402 7; Catalog # PT110-N2 (Neuco). (8) True-Test™ Pregnancy Test Kit (Examen del Embarazo) One Step Testing --- 1 Test --- Distributed By: Ultras Pharmaceuticals, Inc. P.O. Box 370669 Las Vegas, NV 89137 U.S.A.; UPC 0 61406 37505 5; Catalog # PT110-R1 (Ultras). (9) Shaw's ONE-STEP Pregnancy Test ---1 TEST --- DISTRIBUTED BY SHAW'S SUPERMARKETS, INC. E. BRIDGEWATER, MA 02333, Made in USA; UPC 0 45674 65589 7; Catalog # PT110-S1 (Millbrook Distribution). (10) Harris Teeter Pregnancy Test Kits One Step Easy to use Pregnancy Test Kit --- Two Home Test Kits --- PROUDLY DISTRIBUTED BY: HARRIS TEETER MATTHEWS, NC 28105; UPC 0 72036 72061 0; Catalog # PT112-R2 (Harris Teeter). Bulk packaged product is assigned Catalog # PT110, with varying quantities (ordered by Savyon Diagnostics & Pruebas Moderna del Istmo). --- 510(k) K961965.

    FDA Recall
    Terminated ·Chembio Diagnostic System Inc·Product code LCX·October 6, 2004

    Sickle-STAT Test Kit, Catalog # SC901, a qualitative test kit for the determination of the presence of hemoglobin S in human blood --- FOR IN VITRO DIAGNOSTIC USE --- FOR PROFESSIONAL USE ONLY --- Contents: 48 pre-filled Sickle-STAT reaction tubes containing sodium hydrosulfite. 1 bottle phosphate buffer containing surfactant and stabilizer, and 1 Instruction leaflet. --- manufactured by: CHEMBIO DIAGNOSTIC SYSTEMS, INC., MEDFORD, NY 11763 --- Accessories available: SC902: Sickle-STAT 5-place Observation rack, SC903: Sickle-STAT Hemoglobin S Control Set; 4 x 1 vials: 2 A/A negative and 2 A/S positive, SC904: Sickle-STAT Phosphate Buffer, 200 ml.

    FDA Recall
    Terminated ·Chembio Diagnostic System Inc·Product code GHM·December 16, 2005

    OTC Pregnancy Tests. Name: Sure Check hCG Cassette Pregnancy Test. --- Description: the Sure Check hCG Cassette Pregnancy test consists of a lateral flow membrane pad containing anti- hCG monoclonal antibody conjugated to colloidal gold contained in a plastic cassette. It differs from the Sure Check Midstream product in that the lateral flow membrane pad is placed in a cassette and the urine sample is added by pipette rather than by urinating on the absorbent wick. The device is packaged in a foil pouch with desiccant. This product is shipped as bulk packaged product of varying quantities (Catalog # PT127-OTC ordered by Innovative Chemical Co., and Pruebas Moderna Del Istmo; Catalog # PT210 ordered by LABSCO). --- 510(k) K933529/A.

    FDA Recall
    Terminated ·Chembio Diagnostic System Inc·Product code LCX·October 6, 2004