FDA device listing

Wash Solution A Concentrate

FDA device listing 2048218484 · Bio-Rad Laboratories (Bio-Rad Services France)

Key facts

Proprietary names Wash Solution A Concentrate
Owner/operator Bio-Rad Laboratories (Bio-Rad Services France)
Owner/operator number 10078397
Product codes GIF
Device names GIF - Diluent, Blood Cell
Device class Class I
Classification regulations (21 CFR) 864.8200
Review panels Hematology
Registered establishments BIO-RAD MEDICAL LABORATORIES LOGISTIK GMBH
Establishment registrations 3016014873
FEI numbers 3016014873
Establishment operations Foreign Exporter
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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