Sure Check hCG Cassette Pregnancy Test

  • Model / Serial
    Lot U040904 (Exp. 30 SEP 06) ; Recall Expansion: lot U032904/1 (Exp. 30 AUG 06 - 14,364 units distributed)
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributors in KS, TN, NC, MA, NY, KY, FL, NV, and Puerto Rico for further distribution to their retail customers. Products also distributed to accounts in Barbados WI, Israel, Costa Rica and Canada.
  • Product Description
    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.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Chembio Diagnostic System Inc, 3661 Horseblock Road, Medford NY 11763-2215
  • Source
    USFDA