UDI device identifier

SPOTCHEM™ II Basic Panel 1 77126

UDI device identifier 00015482771263 · Arkray USA, Inc.

Key facts

Primary DI 00015482771263
Brand name SPOTCHEM™ II Basic Panel 1
Version or model 77126
Company Arkray USA, Inc.
DUNS number 008171162
Product code CGA
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 calcium, blood urea nitrogen (BUN), glucose, albumin, and creatinine concentration in human plasma from whole blood samples

At a glance

  • None MAUDE reports citing this UDI
  • No Linked premarket submission
  • No EUDAMED counterpart found
  • 100–999 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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