AMERICAN RED CROSS DIAGNOSTIC MANUFACTURING DIVISI

FDA Device Registration & Listing · GAITHERSBURG, MD, US · Registration 1177732

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1177732
FEI Number
1177732
Entity Name
AMERICAN RED CROSS DIAGNOSTIC MANUFACTURING DIVISI
City/State/Country
GAITHERSBURG, MD, US
Establishment Address
9319 Gaither Rd, GAITHERSBURG, MD 20877, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
AMERICAN NATIONAL RED CROSS HEADQUARTERS (Owner Number: 9024647)
Owner / Operator Contact Address
431 18th Street NW, --, Washington, DC 20006, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
BK090021
PMA Number
N/A

All Registered Proprietary Names

Red Cell Storage Solution (RCSS) 0.2M Dithiothreitol (DTT) Control Cells

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GIF Diluent, Blood Cell Hematology Class 1 864.8200 1996-12-31
PPM General Purpose Reagent Pathology Class 1 864.4010 2024-12-27
KSF Kit, Quality Control For Blood Banking Reagents Hematology Class 2 864.9650 2009-10-26

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

AMERICAN NATIONAL RED CROSS HEADQUARTERS
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1177732. Last updated year: 2026. Please use registration number 1177732 when referencing this establishment in official correspondence.
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