Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1050190

FEI Number

1050190

Entity Name

CENTERS FOR DISEASE CONTROL AND PREVENTION

City/State/Country

ATLANTA, GA, US

Establishment Address

1600 CLIFTON RD., N.E., ATLANTA, GA 30333, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

U.S. GOVERNMENT DEPARTMENT HHS (Owner Number: 1050190)

Owner / Operator Contact Address

1600 CLIFTON RD., N.E., ATL, GA 30329, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

DEN160016

PMA Number

N/A

All Registered Proprietary Names

ANTISERUM, FLUORESCENT, FRANCISELLA TULARENSIS ANTISERUM, VIBRIO CHOLERAE, ALL VARIETIES ANTISERUM, TYPHUS FEVER Francisella tularensis Real-time PCR Assay Rickettsia Spp. Nucleic Acid Based Detection Assay ANTIGEN, CF, SPOTTED FEVER GROUP ANTIGEN, CF, TYPHUS FEVER GROUP B. anthracis Real-time PCR Assay ANTISERA, ALL GROUPS, SALMONELLA SPP. ANTIGEN, CF, Q FEVER Gamma Phage Lysis Assay for the Identification of Bacillus anthracis CDC DENV-1-4 REAL TIME RT-PCT ASSAY Variola virus Real-time PCR Assay

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GSJ	Antiserum, Fluorescent, Francisella Tularensis	Microbiology	Class 2	866.3280	1978-06-28
GSQ	Antiserum, Vibrio Cholerae, All Varieties	Microbiology	Class 2	866.3930	1978-06-28
GPN	Antiserum, Typhus Fever	Microbiology	Class 1	866.3500	1978-06-28
SGA	Biothreat Microbial Agent Nucleic Acid Detection Test	Immunology	Class 2	866.4000	2026-02-05
PVQ	Rickettsia Spp. Nucleic Acid Based Detection Assay	Microbiology	Class 2	866.3316	2020-01-24
GPQ	Antigen, Cf, Spotted Fever Group	Microbiology	Class 1	866.3500	1978-06-28
GPO	Antigen, Cf, Typhus Fever Group	Microbiology	Class 1	866.3500	1978-06-28
NHT	Assay, Nucleic Acid Amplification, Bacillus Anthracis	Microbiology	Class 2	866.3045	2020-01-24
GRM	Antisera, All Groups, Salmonella Spp.	Microbiology	Class 2	866.3550	1978-06-28
GPS	Antigen, Cf, Q Fever	Microbiology	Class 1	866.3500	1978-06-28
NVQ	Bacteriophage And Controls, B. Anthracis Lysis	Microbiology	Class 2	866.3045	2017-05-08
OZB	Dengue Nucleic Acid Amplification Assay (Naat)	Microbiology	Class 2	866.3946	2015-05-22
PRA	Variola Virus Nucleic Acid-Based Detection Assay	Microbiology	Class 2	866.3316	2017-05-08

Official Correspondent

DR. DENNIS BAGAROZZI JR.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

U.S. GOVERNMENT DEPARTMENT HHS

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 1050190. Last updated year: 2026. Please use registration number 1050190 when referencing this establishment in official correspondence.