FDA device listing

MTS Work Table

FDA device listing 1247019908 · QuidelOrtho Corporation

Key facts

Proprietary names MTS Work Table
Owner/operator QuidelOrtho Corporation
Owner/operator number 2024674
Premarket submissions BK950026
Product codes KSS
Device names KSS - Supplies, Blood-Bank
Device class Class I
Classification regulations (21 CFR) 864.9050
Review panels Hematology
Registered establishments MICRO TYPING SYSTEMS, INC.
Establishment registrations 1056600
FEI numbers 1000132079
Establishment operations Specification Developer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None UDI devices (GUDID) under the same submission
  • 1–9 Device listings citing the same submission
  • Yes Premarket submission listed

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device listings

Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.

Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database

Browse all FDA device listings