Devices

Device Recall ULTRACRP

  • Model / Serial
    Lot numbers 1155J (EXP. 09/04) and 1388J (EXP. 10/04)
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Medical facilities, physicians, diagnostic laboratories, and distributors located nationwide.
  • Product Description
    POLYMEDCO ULTRA-CRP LATEX ENHANCED ASSAY, Catalog No. CPU400. Contents: 1 x 50 ML R1, 2 x 6 ML R2. R1 is the HIGH SENSITIVE CRP Buffer IVD (50 ml). R2 is the HIGH SENSITIVE CRP Latex IVD (6 ml). For In Vitro Diagnostic (IVD) use only. || COMMON/USUAL NAME: High-Sensitive C-Reactive Protein --- CLASSIFICATION NAME: C-reactive Protein, Antigen, Antiserum
  • Manufacturer
    Polymedco, Inc
  • 1 Event

Manufacturer

Polymedco, Inc
  • Manufacturer Address
    Polymedco, Inc, 510 Furnace Dock Road, Cortlandt Manor NY 10567-6220
  • Source
    USFDA

One device with a similar name

Learn more about the data here

Device Recall ULTRACRP
  • Model / Serial
    Lot numbers CP4274-0769M (EXP. 09/04) and CP4335-0812M (EXP. 11/04)
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Medical facilities, physicians, diagnostic laboratories, and distributors located nationwide.
  • Product Description
    POLYMEDCO ULTRA-CRP High Sensitive Assay For the DIMENSION(R) systems, Catalog No. USC300. Contents: 4 x 50 Tests. For In Vitro Diagnostic (IVD) use only. || COMMON/USUAL NAME: High-Sensitive C-Reactive Protein --- CLASSIFICATION NAME: C-reactive Protein, Antigen, Antiserum.
  • Manufacturer
    Polymedco, Inc