Stratus Cs D-Dimer (Ddmr) Method (Testpak & Dilpak), Models Cddmr & Cddmr-D

• • Terminated Z-0883-06 FDA Unclassified (pre-2012) ·initiated 3 Apr 2006

  Foil sealing of the DilPak may occlude the pipet tip resulting in insufficient aspiration of fluids. Erroneous test results may be generated without an associated error code. Test results may be falsely elevated or depressed, and the magnitude of the inaccuracy may vary based on the degree of occlusion.

510(k) Number

K022976 ↗

FDA Product Code

DAP

Device Class

Class II

Regulation

21 CFR Part 864.7320

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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