UDI device identifier

SPOTCHEM™ II CPK 77112

UDI device identifier 00015482771126 · Arkray USA, Inc.

Key facts

Primary DI 00015482771126
Brand name SPOTCHEM™ II CPK
Version or model 77112
Company Arkray USA, Inc.
DUNS number 008171162
Product code CGS
GMDN term Magnesium (Mg2+) IVD, kit, spectrophotometry
Device class Class II
Single use Yes
Packaged sterile No
Implantable No
Publish date Sep 23, 2016
Version date Aug 24, 2026
Description Strip description for the invitro quantitative determination of creatine kinase (creatine phosphokinase or CPK) activity in human plasma from whole blood samples

At a glance

  • None MAUDE reports citing this UDI
  • No Linked premarket submission
  • No EUDAMED counterpart found
  • 10–99 GUDID devices with this product code

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

About UDI device identifiers (GUDID)

The Global Unique Device Identification Database (GUDID) holds the device identifiers (UDI-DIs) and key attributes that labelers submit to the FDA for devices that carry a unique device identifier.

Source: U.S. FDA Global Unique Device Identification Database (GUDID), via NLM AccessGUDID · Source date:

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