Oxoid Legionella Latex Test

  • Model / Serial
    DR0802M box lot 1301909, Exp. 30Sep2014
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including AZ, CA, DC, FL, IL, ME, NJ, NY, PA, VA, and VT.
  • Product Description
    Oxoid Legionella Pneumo Groups 2-14 Latex Test, DR0802M, containing 50 tests per box. The box contains a variety of components, one of which is Oxoid L. pneumophila Group 2-14 Latex Reagent, Lot 1301912. The product is a latex agglutination test for the identification of predominant Legionella species grown on plate media from patients with suspected Legionellosis or from environmental sources. The test allows a separate identification of Legionella pneumophila serogroup 15 and serogroups 1-14 and detection of other pathogenic non L. pneumophila, Legionella strains.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Remel Inc, 12076 Santa Fe Trail Dr, Lenexa KS 66215-3519
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

4 devices with a similar name

Learn more about the data here

  • Model / Serial
    DR0800M box lot numbers 1314413, Exp. 30Jun2014, and 1301907, Exp. 31May2014; DR0802 reagent bottle lot number 1265366, exp. June 2014
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distribution was made to CA, FL, IL, MA, ME, NJ, PA, TN, TX, VA, and VT. There was no foreign/military/government distribution.
  • Product Description
    Oxoid Legionella Latex Test, DR0800M, containing 50 tests per box. The box contains a variety of components, one of which is Oxoid L. pneumophila Group 2-14 Latex Reagent, DR0802. The responsible firm on the label is Oxoid Ltd., Basingstoke, Hants, England.
  • Manufacturer
  • Model / Serial
    DR0800M box lot 1316151, Exp. 30Sep2014
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including AZ, CA, DC, FL, IL, ME, NJ, NY, PA, VA, and VT.
  • Product Description
    Oxoid Legionella Latex Test, DR0800M, containing 50 tests per box. The box contains a variety of components, one of which is Oxoid L. pneumophila Latex Reagent, DR0802, Lot 1301912. The responsible firm on the label is Oxoid Ltd.
  • Manufacturer
  • Model / Serial
    Oxoid Legionella Latex Test and Oxoid Legionella Penumophila Serogroup 2-14 Test Reagent (an in vitro diagnostic medical device (IVD))Oxoid Legionella Latex Test (DR0800M)Lot Numbers: 1314413 and 1301907Oxoid Legionella Pneumophila Serogroup 2-14 Test Reagent (DR0802M)Lot Number: 1265362
  • Manufacturer