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FEI 3002800697 · Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device · Status: Active

FEI Number3002800697
Owner / OperatorBIOCHECK, INC. (#9033543)
AddressFRAUENBERGSTRASSE 18, MARBURG Hesse, D-35039, DE
Mandatory US AgentDRG International, Inc.
Registration expiry2026
Initial importer flagN
Registered products1
Product codes (top 20)JKD
Regulation § (21 CFR)862.1135
Proprietary namesC-Peptide ELISA, Insulin (human) Ultrasensitive ELISA

External sources

Source: openFDA. Public-domain (CC0).