Remel, Inc

12 devices in the database

  • Model / Serial
    10 pack - Lot #384341, Exp. 11/03/2003; 15 pack - Lot #384342, Exp. 11/3/2003; 100/cs - Lot #384343
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distribution was made nationwide to facilities with medical laboratories, including military and government facilities.
  • Product Description
    Remel Thayer Martin Agar (Improved), packaged in 10-packs (Cat. #01884), 15-packs (Cat. #01885), and 100 per case (Cat. #01886). The responsible firm on the label is Remel, Lenexa, KS.
  • Model / Serial
    Lot numbers 597374, Exp. 2008.10.08; 607636, Exp. 2008.11.06; 615970, Exp. 2008.12.02; 615971, Exp. 2008.12.02; 621187, Exp. 2008.12.02; 622617, Exp. 2009.04.02; 624618, Exp. 2009.01.02; 635553, Exp. 2009.04.17; 635554, Exp. 2009.04.24; 640609, Exp. 2009.05.01; 654829, Exp. 2009.05.30; and 658878, Exp. 2009.05.30
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- including USA and countries of Canada and U.K.
  • Product Description
    Xpect Giardia/Cryptosporidium Kit, Ref 24050520, 20 tests per kit, For In Vitro Diagnostic Use. || A rapid test for the direct qualitative detection of Giardia and Cryptosporidium antigens in fecal specimens.
  • Model / Serial
    Lot No. J311510, Expiry Date 2009.04.30, and Lot J477610, Expiry Date 2009.10.31;  Lot No. J311610, Expiry Date 2009.04.30; Lot No. J477710, Expiry Date 2009.10.31; and J359510, Expiry Date 2009.07.31
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA and Canada.
  • Product Description
    Remel Staphaurex Plus Kit, Catalog No. R30950102 (150 tests) and Catalog No. R30950201 (450 tests), rapid latex agglutination test for the identification of Staphylococcus aureus The responsible firm listed as Remel Europe Ltd, Dartford, England.
  • Model / Serial
    Lot 763654, Exp. 2009.07.07
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- including states of FL, NJ, IN, FL, OH, KY, TX, and WI.
  • Product Description
    Remel Middlebrook 7H10 Agar, Ref R01600, packaged 10 units/package. The firm name on the label is Remel, Lenexa, KS. || Solid Medium recommended for use in qualitative procedures for the isolation and cultivation of mycobacteria.
  • Model / Serial
    Lot 725080, Exp. 2013.05.28
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Remel BactiSwab NPG Collection and Transport System, Sterile, 100 swab units/box, Catalog 12300. The firm name on the label is Remel, Lenexa, KS. || Collection and transportation of clinical specimens to the laboratory for microbiological examination when swab collection is appropriate.
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4 manufacturers with a similar name

Learn more about the data here

  • Manufacturer Address
    Remel, Inc., 12076 Santa Fe Dr, Lenexa KS 66215
  • Source
    USFDA
  • Manufacturer Address
    Remel, Inc., 12076 Santa Fe Trail Dr, Lenexa KS 66215-3519
  • Source
    USFDA
  • Manufacturer Address
    Remel, Inc., 12076 Santa Fe Trail Dr, (PO Box 14478, zip 66285-4478), Lenexa KS 66215-3519
  • Source
    USFDA
  • Manufacturer Address
    Remel, Inc., 12076 Santa Fe Trail Dr, Lenexa KS 66215
  • Source
    USFDA