Devices

IgM ELISA Kit

  • Model / Serial
    Lot #040531.
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product distributed to a single direct account in CT.
  • Product Description
    american diagnostica inc. IgM Conjugate, 15mL; component of the american diagnostica, inc. IMUCLONE¿ aPL IgM ELISA Kit, Product #649M; manufactured by Louisville APL Diagnostics, Inc., Seabrook, TX 77586.
  • Manufacturer
    Louisville Apl Diagnostics Inc
  • 1 Event

Manufacturer

Louisville Apl Diagnostics Inc
  • Manufacturer Address
    Louisville Apl Diagnostics Inc, 2622 NASA Parkway, Suite G2, Seabrook TX 77586-3447
  • Source
    USFDA

4 devices with a similar name

Learn more about the data here

APHL HRP IGM ELISA KIT
  • Model / Serial
    Model Catalog: LAPL-K-HRP-001M (Lot serial: 050723); Model Catalog: LAPL-K-HRP-001GM (Lot serial: 050723)
  • Product Description
    IgM HRP ELISA Kit
  • Manufacturer
    LOUISVILLE APL DIAGNOSTICS INC.
Device Recall APhL HRP IgG & IgM ELISA Kit
  • Model / Serial
    Lot #060425. Lot number on the outer packaging of the received kits was 060308.
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was shipped to a distributor in Canada.
  • Product Description
    APhL¿ HRP IgG & IgM ELISA Kit; Ref. #LAPL-K-HRP-00GM; in vitro diagnostic. Distributed by Louisville APL Diagnostics, Inc., Doraville, GA 30360 (address now in Seabrook, TX 77856).
  • Manufacturer
    Louisville Apl Diagnostics Inc
APhL HRP IgG & IgM ELISA Kit
  • Model / Serial
    Lot #050723
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    World Wide: Product distributed to direct accounts in CA, FL and GA. Foreign consignees located in Canada and Turkey.
  • Product Description
    APhL¿ HRP IgG & IgM ELISA Kit; Ref. #LAPL-K-HRP-00GM; distributed by Louisville APL Diagnostics, Inc., Doraville, GA 30360- Quality Control Fact Sheets for the Louisville APL Diagnostics, Inc. (address now in Seabrook, TX 77586).
  • Manufacturer
    Louisville Apl Diagnostics Inc
APhL HRP IgM ELISA Kit
  • Model / Serial
    Lot #050723
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    World Wide: Product distributed to direct accounts in CA, FL and GA. Foreign consignees located in Canada and Turkey.
  • Product Description
    APhL¿ HRP IgM ELISA Kit; Ref. #LAPL-K-HRP-001M; distributed by Louisville APL Diagnostics, Inc., Doraville, GA 30360-- Quality Control Fact Sheets for the Louisville APL Diagnostics, Inc. --(current address now in Seabrook, TX 77586).
  • Manufacturer
    Louisville Apl Diagnostics Inc