Skip to content

CD19 (Rm) [RM332] ALI3270G7

by Biocare Medical, LLC

CD19 (Rm) [RM332] ALI3270G7 is a Class I device made by Biocare Medical, LLC, listed in FDA GUDID since 23 Sep 2022 (UDI-DI 00847627028334), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00847627028334 UDI-DI Date23 Sep 2022ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
CD19 (Rm) [RM332]
Generic name
CD19 cell marker IVD, antibody
Model / reference
ALI3270G7
Primary DI / UDI-DI
00847627028334
FDA product code
NJT
GMDN term
CD19 cell marker IVD, antibody
Device class
Class I
Regulation number
864.1860
GUDID distribution status
In Commercial Distribution

Related devices

Category: CD19 cell marker IVD, antibody

Similar devices in this category

Other devices filed under CD19 cell marker IVD, antibody.

Other devices from Biocare Medical, LLC

See all devices from Biocare Medical, LLC →

Properties

  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)