Manufacturers

Biogenex Laboratories

6 devices in the database

BioGenex Super Sensitive LinkLabel IHC Detection System
  • Model / Serial
    Catalog Number QP300-XAK, Lot numbers QP3000905B, QP3000905C, QP3001205B, QP3001005, QP3001205, QP3000206, QP3001205C, QP3000506, QP3000506B, QP3000506C, QP3000606, QP3000706.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide-USA (including VA Medical Center) and Greece, Jordan, France, India, Taiwan, United Kingdom, Turkey, and Italy
  • Product Description
    Super Sensitive Link-Label IHC Detection System/Mega Volume, RTU Multi-Link-HRP, REF/Cat. No. QP300-XAK, Kit containing reagent vials, Bio-Genex, San Ramon, CA.
BioGenex
  • Model / Serial
    Catalog Number AM371-5M, Lot number AM3710606, Expiration date June 2008.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution --- including state of Texas and countries of Amman, Jordan, and India.
  • Product Description
    Anti-CD45 Cocktail antibody in 6 ml vials; Cat. No. AM371-5M , manufactured and distributed by BioGenex, San Ramon, CA
Device Recall Xmatrx FISH
  • Model / Serial
    Serial Numbers: AS40211, AS40226, AS40230, AS40231, AS40232, AS40233, AS40234, AS40235, AS40236, and AS40237
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    The firm distributed the product to one (1) distributor as a consignee of our product. The firm indicated that no customer has received the product directly from BioGenex, due to the fact that the product is exclusive distributed by Abbott Molecular.
  • Product Description
    Xmatrx FISH (fluorescent in situ hybridization) Automated Staining System; Model Number/Catalog Number: AS4010B; || The product is manufactured by: BioGenex Laboratories, Inc. 4600 Norris Canyon Road San Ramon, CA 94583 and Distributed by: Abbott Molecular, 1300 E. Touhy Ave - 2E, Des Plaines, IL 60018 || Xmatrx Automated Staining System is intended for in vitro diagnostic use. It is suitable for fluorescent hybridization (FISH) applications.
Device Recall Xmatrx FISH Automated Staining System
  • Model / Serial
    Serial numbers AS40211, AS40226, AS40230, AS40231, AS40232, AS40233, AS40234, AS40235, AS40236, AS40237. These serial numbers encompass ALL products distributed.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Product was distributed to a single distributor, which further distributed the product.
  • Product Description
    Xmatrx FISH (fluorescent in situ hybridization) Automated Staining System, Catalog number AS4010B
Device Recall BioGenex
  • Model / Serial
    Lot Numbers:  AM3640305,  AM3640404, AM3640406, AM3640505,  AM3640804, AM3640804X, MU3640305, MU3640504, MU3641004, MU3641005
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    BioGenex brand Hepatitis B Virus Surface Antigen Antibody, Cat. No. AM364-5M and MU364-UC, || Product is distributed by BioGenex Laboratories, 4600 Norris Canyon Rd., San Ramon, CA 94583
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2 manufacturers with a similar name

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Biogenex Laboratories
  • Manufacturer Address
    Biogenex Laboratories, 4600 Norris Canyon Rd, San Ramon CA 94583-1320
  • Source
    USFDA
Biogenex Laboratories, Inc.
  • Manufacturer Address
    Biogenex Laboratories, Inc., 49026 Milmont Dr, Fremont CA 94538-7301
  • Source
    USFDA