Pure Global AI
FDA product code CIW

Starch-Dye Bound Polymer, Amylase

Clinical ChemistryClass 221 CFR 862.1070
Verified
US regulatory classifications
US Product Code (FDA)
CIW
View Product Code Classification
US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 862.1070
View CFR Regulation
Medical specialty
Clinical Chemistry
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Eligible
Search keywords

Click to search for similar devices in our global database

01Amylase test02amylase reagent03enzyme assay04diagnostic reagent05pancreatic test06lab test07starch assay08dye bound09enzyme measurement10diagnostic system
About this record

Starch-Dye Bound Polymer, Amylase is a medical device type in the Clinical Chemistry specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.