Home
gpo.gov
govinfo.gov

e-CFR Navigation Aids

Browse

Simple Search

Advanced Search

 — Boolean

 — Proximity

 

Search History

Search Tips

Corrections

Latest Updates

User Info

FAQs

Agency List

Incorporation By Reference

eCFR logo

Related Resources

Electronic Code of Federal Regulations

We invite you to try out our new beta eCFR site at https://ecfr.federalregister.gov. We have made big changes to make the eCFR easier to use. Be sure to leave feedback using the Feedback button on the bottom right of each page!

e-CFR data is current as of March 2, 2021

Title 21Chapter ISubchapter HPart 864Subpart J → §864.9225


Title 21: Food and Drugs
PART 864—HEMATOLOGY AND PATHOLOGY DEVICES
Subpart J—Products Used In Establishments That Manufacture Blood and Blood Products


§864.9225   Cell-freezing apparatus and reagents for in vitro diagnostic use.

(a) Identification. Cell-freezing apparatus and reagents for in vitro diagnostic use are devices used to freeze human red blood cells for in vitro diagnostic use.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to §864.9.

[45 FR 60643, Sept. 12, 1980, as amended at 65 FR 2310, Jan. 14, 2000]

Need assistance?