MedtechSourcebook

AMERICAN RED CROSS DIAGNOSTIC MANUFACTURING DIVISI

Contract manufacturer ยท Gaithersburg, MD

FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified

FDA registration
1177732 (openFDA record; or search FDA's registration database)
FEI number
1177732
Registered for
FDA registration year 2026
Establishment types
Manufacturer; Contract manufacturer
Owner or operator
AMERICAN NATIONAL RED CROSS HEADQUARTERS (FDA owner/operator no. 9024647)
Registered address
9319 Gaither Rd, Gaithersburg, MD 20877
Contract listings
1 device listings, 1 product codes, first listed Dec 27, 2024
Certification
Not verified. We have no certification data for this facility yet.

Devices listed as contract work

Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.

Product codeDevice (FDA name)ClassCategoryRoleFirst listed
PPMGeneral Purpose ReagentClass IPathologyContract manufacturingDec 27, 2024