FDA device listing

A-1-Antichymotrypsin Positive Control Slides,A-1-Antitrypsin Positive Control Slides,ACTH Positive Control Slides,Actin…

FDA device listing 1551656494 · MilliporeSigma

Key facts

Proprietary names A-1-Antichymotrypsin Positive Control Slides,A-1-Antitrypsin Positive Control Slides,ACTH Positive Control Slides,Actin, Muscle Specific Positive Control Slides,Actin, Smooth Muscle Positive Control Slides,Adenovirus Positive Control Slides,Adipophilin Positive control slides,,ALDH1A1 Positive Control Slides,ALK Protein Positive Control Slides,Alpha-Fetoprotein Positive Control Slides,Androgen…
Owner/operator MilliporeSigma
Owner/operator number 1216103
Product codes KEW
Device names KEW - Slides, Microscope
Device class Class I
Classification regulations (21 CFR) 864.3010
Review panels Pathology
Registered establishments CELL MARQUE CORP.
Establishment registrations 1649339, 3017212430
FEI numbers 3000718726, 3017212430
Establishment operations Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None listed 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

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