Devices

Dimension Vista(R) Total Prostate Specific Antigen Flex(R) reagent cartridge

Model / Serial
Catalog number: K6451; Mnemonic: TPSA; lot number 11300BB, exp 10/26/2012
Product Classification
Immunology and Microbiology Devices
Device Class
3
Implanted device?
No
Distribution
USA Nationwide Distribution including the states of: AL, AZ, CA, CO, CT, FL IL, LA, MD, MI, MN, MS, MT, NC, NH, NJ, NV, NY, OH, PA, SD, TN, TX, UT, WI ,WV including Puerto Rico.
Product Description
Dimension Vista(R) Total Prostate Specific Antigen Flex(R) reagent cartridge || Product Usage: || The TPSA method is an in vitro diagnostic test for the quantitative measurement of total prostate specific antigen (PSA) in human serum and plasma on the Dimension Vista(R) System
Manufacturer
Siemens Healthcare Diagnostics, Inc.
1 Event
- Recall of Dimension Vista(R) Total Prostate Specific Antigen Flex(R) reagent cartridge

Manufacturer

Siemens Healthcare Diagnostics, Inc.

Manufacturer Address
Siemens Healthcare Diagnostics, Inc., 500 GBC Drive, Mailstop 514, PO BOX 6101, Newark DE 19714-6101
Manufacturer Parent Company (2017)
Siemens Ag
Source
USFDA

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