Devices

Device Recall Syva Emit 2000 Theophylline Assay

  • Model / Serial
    ADVIA¿ Chemistry (Syva Onboard) Theophylline_2 (THEO_2) Reagent - SMN# 10377503, Lot # 334018
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed to: CA, CT, DE, FL, GA, IA, IN, KS, KY, LA, MA, MD, MI, MO, NC, NJ, NM, NY, OH, OK, PA, TN, VA, WA
  • Product Description
    ADVIA¿ Chemistry (Syva Onboard) Theophylline_2 (THEO_2) Reagent is for in vitro diagnostic use in the quantitative analysis of theophylline in human serum or plasma on the ADVIA¿ Chemistry Systems. || Copies of IFUs included in submission.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.
  • 1 Event

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • Manufacturer Address
    Siemens Healthcare Diagnostics, Inc., 500 Gbc Dr Ms 514, PO BOX 6101, Newark DE 19702-2466
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA

One device with a similar name

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Device Recall Syva Emit 2000 Theophylline Assay
  • Model / Serial
    Catalog # 4P019UL /SMN#10445324 kit lot J1 (UDI# 00842768001024J120190414)
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution
  • Product Description
    Syva¿ EMIT¿ 2000 Theophylline || Product Usage: || The Syva¿ Emit¿ 2000 Theophylline Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of theophylline in human serum or plasma.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.