Abbott Health Products, Inc.

14 devices in the database

  • Model / Serial
    Lot # 18220Q100 Exp. March 02, 2005
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product has been distributed to hospitals, laboratories and other institution including government accounts. Geographic areas of distribution include Puerto Rico, Canada, Germany, Thailand and U.S.A. Government accounts includes: VA Medical Center, Saint Louise, MO; Brecksville VA Hosp. Supp, Brecksville, OH; VA MED CENTER, Phoenix, AZ; Department Veterinary Affair Med., Houston, TX; VA Med., Cincinnati, OH; VA Med Center, Seattle, WA; Truman Mem. VA, Columbia, MO; Dept. Vet. Aff., Shreveport, LA; VA Hosp. Whse., Fresno, CA ; VA Med Center, Omaha, NE ; VA Med. Center, Lexington, KY; VA Med Center, Detroit, MI ; VA Hosp., San Diego, CA ; Naval Hosp., Great Lakes, IL; VA Med. Center, San Francisco, CA.
  • Product Description
    IMx HAVAB Controls are for In Vitro Diagnostic use. The kit is composed of 2 bottles of Negative and Positive controls of 9 mL each. These are prepared with recalcified human plasma and the preservative is Sodium Azide. The Negative Control is non-reactive for HbsAG, HIV-1, Anti-HCV, anti-HiV-1/HIV-2 and IgG antibody against HAV. The Positive Control is recalcified human plasma for anti-HAV diluted with Negative Control.
  • Model / Serial
    25459Q100
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Goverment, Domestic and International distribution.
  • Product Description
    IMx total B-hCG Reagent is composed of one bottle of Coated Microparticles, one bottle of Alkaline Phosphatase Conjugate, one bottle of 4 Methylumbelliferyl Phosphate and one bottle of Specimen Diluent
  • Model / Serial
    2614Q100 (5/13/2005);  26278Q100, 26381Q100 (6/21/2005)
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Domestic , US Goverment and International ditribution.
  • Product Description
    AxSYM total B-hCG Reagent is composed of one bottle of Coated Microparticles, one bottle of Alkaline Phosphatase Conjugate and one bottle of Specimen Diluent.
  • Model / Serial
    Lot # 21059Q100 Expiration Date: May 20, 2005
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The recalled IMx HAVAB Controls were distributed nationwide in the United Stated, including Puerto Rico and internationally were distributed to Canada, Peru, Germany, Japan, Australia, and Singapore. There are US Government accounts.
  • Product Description
    IMx HAVAB Controls In Vitro Test
  • Model / Serial
    Lot #: 18357Q100, 18357Q101 (France), 18357Q102, 18357Q103 and 18357104(France). Exp. date 11/11/04
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distribution was nationwide to laboratories and to the following government accounts: 375th MEDCL GRP, Scott AFB, IL, Logistic Div USA MEDDAC, Fort Drum, NY, MED MAT SVC SGSL, Colorado Springs, CO, Naval Hosp RCVG OFCR, Charleston, SC, Keller Army Hosp MED SUP, West Point, NY, 325 MED GRP SGSL, Tyndall AFB, FL, VA Hosp Whse 90D, Miami, FL, VA MED CTR, Danville, IL, VA MED CTR, Amarillo, TX, VA MED CTR, Columbia, SC, VA MED CTR, Milwaukee, WI, 1st Med GRP, Langley AFB, VA, VA MEDCL CTR, Charleston, SC, VA MEDCL CTR, Albuquerque, NM, USH S IND Hosp., Lawton, OK, POST MED SP HSXA LOG, Fort Belvoir, VA, 366 MEDCL GRP SGSL, MTN HOME AFB, ID, Dover AFB FM, Dover AFB, DE, WEED Army COMM Hosp, Fort Irwin, CA, SHAW AFB 20th MDS SGSL, Shaw AFB, SC, William W Hasting Hosp, Tahlequah, OK, USPHS San Fidel, San Fidel, NM, Cherokee Indian Hosp, Cherokee, NC, Mount Edgecumbe Hosp, Sitka, Ak, CONTR OFFICER, Lemore, CA, FOREST CNTY POTAWATOMI, Crandon, WI, Naval Hosp, Pensacola, FL, Naval Hosp Comm OFFR, Great Lakes, IL, CONTR OFFICER, Bremerton, WA, MEDCL CTR FED PRISIONERS, Springfield, MO, PHS INDIAN HOSP, Fort Yates, ND Foreign countries: Singapore, Australia, New Zealand, Costa Rica, Ecuador, Chile, Germany, Canada, Mexico, Barbados, St. Vincent and Bermuda.
  • Product Description
    AxSYM Total B-hCG Reagent, Product list number: 7A59-22 and 7A59-21
9 more

One manufacturer with a similar name

Learn more about the data here

  • Manufacturer Address
    Abbott Health Products, Inc., Hwy 2 Km 58.0, Cruze Davila, Barceloneta PR 00617
  • Source
    USFDA