CENTERS FOR DISEASE CONTROL AND PREVENTION

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1050190	1050190	CENTERS FOR DISEASE CONTROL AND PREVENTION	1	N	2026-01-01	1600 CLIFTON RD., N.E. ATLANTA GA US 30333

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
767	1717666943	K252072	Francisella tularensis Real-time PCR assay	SGA	2025-09-30
767	1388086896	K243274	CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A SubTyping Kit (VER 4); Influenza B Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4)	OZE	2025-07-11
767	1986095068	K222558	Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set	PBK	2022-08-30
767	1547436930	K192871	B. anthracis Real-time PCR Assay	NHT	2019-11-07
767	1267375990	K190302	CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza B Lineage Genotyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/HS Subtyping Kit	OZE	2019-03-27
767	1772540806	K181205	Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set	PBK	2018-09-20
767	1105228027	K170940	Rickettsia Real-time PCR Assay	PVQ	2017-06-29
767	1310063962	K143592	GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRAC	NVQ	2015-04-16
767	1939909229	K140426	ANTHRACIS REAL-TIME PCR ASSAY	NHT	2014-05-22
767	1360095872	K051794	GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRACIS	NVQ	2005-08-16
767	1387474894	DEN160016	Variola virus Real-Time PCR Assay	PRA	2017-02-06
767	1750576676	DEN120012	CDC DENV-1-4 REAL TIME RT-PCT ASSAY	OZB	2012-05-24
767	1006707369
767	1025625617
767	1050871231
767	1059495362
767	1074201239
767	1078670770
767	1090906792
767	1104154472
767	1109722531
767	1129891692
767	1179016933
767	1187667107
767	1202906316
767	1211378461
767	1231802371
767	1244193250
767	1250198013
767	1274031601
767	1308589439
767	1309531578
767	1319140834
767	1337894839
767	1341496482
767	1344944744
767	1345716461
767	1352816899
767	1375285169
767	1377387072
767	1380608488
767	1402474957
767	1407118432
767	1408532214
767	1416978458
767	1448571872
767	1450795960
767	1461833024
767	1475360329
767	1517382825
767	1528578196
767	1572436212
767	1611052145
767	1627603043
767	1632921335
767	1648236007
767	1654931952
767	1656131857
767	1671123960
767	1706891309
767	1716130296
767	1746803293
767	1774402048
767	1777555058
767	1801351455
767	1825601333
767	1831959578
767	1839900651
767	1873301321
767	1898749350
767	1899733943
767	1916426993
767	1917115153
767	1933908166
767	1956040441
767	1967842120
767	1967936983
767	1989852117
767	1990626951
767	1994112761
767	1998108236
767	2011300116
767	2029438012
767	2065801137
767	1354023986
767	1397934300
767	1526594030
767	1608054559
767	1682943529
767	1727661739
767	2005187992
767	2052549942

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
OZE	2	2025-07-11
PBK	2	2022-08-30
NHT	2	2019-11-07
NVQ	2	2015-04-16
SGA	1	2025-09-30
PVQ	1	2017-06-29
PRA	1	2017-02-06
OZB	1	2012-05-24

PMA#

AFP MID-PREGNANCY REFERENCE PREPARATION
1984-11-30
CENTERS FOR DISEASE CONTROL AND PREVENTION

PMN#

CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4)
2024-05-21
Centers for Disease Control and Prevention
Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
2022-08-30
Centers for Disease Control and Prevention
Non-variola Orthopoxvirus Real-time PCR Primer And Probe Set
2022-06-24
Centers For Disease Control And Prevention
Non-variola Orthopoxvirus Real-time PCR Primer And Probe Set
2022-06-10
Centers For Disease Control And Prevention
CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/H5 Subtyping Kit
2020-03-10
Centers For Disease Control And Prevention
B. Anthracis Real-time PCR Assay
2019-11-07
Centers For Disease Control And Prevention
CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza B Lineage Genotyping
2019-03-27
Centers For Disease Control And Prevention
Non-variola Orthopoxvirus Real-time PCR Primer And Probe Set
2018-09-20
Centers For Disease Control And Prevention
CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage Genotyping Kit,
2018-07-30
Centers For Disease Control And Prevention (CDC)
CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza B Lineage Genotyping
2017-08-09
Centers For Disease Control And Prevention
Rickettsia Real-time PCR Assay
2017-06-29
Centers For Disease Control And Prevention (CDC)
CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit
2016-06-30
Centers For Disease Control And Prevention (CDC)
CDC Human Influenza Virus Real- Time RT-PCR Diagnostic Panel, Influenza A/H5 Subtyping
2015-12-01
CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC)
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL, INFLUENZA A/H5 SUBTYPING
2014-08-01
CENTERS FOR DISEASE CONTROL AND PREVENTION
ANTHRACIS REAL-TIME PCR ASSAY
2014-05-22
CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC)
INFLUENZA B LINEAGE GENOTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
2014-04-25
CENTERS FOR DISEASE CONTROL AND PREVENTION
INFLUENZA A SUBTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
2014-04-25
CENTERS FOR DISEASE CONTROL AND PREVENTION
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
2013-09-23
CENTERS FOR DISEASE CONTROL AND PREVENTION
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
2013-05-22
CENTERS FOR DISEASE CONTROL AND PREVENTION
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
2013-01-14
CENTERS FOR DISEASE CONTROL AND PREVENTION
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
2011-08-23
CENTERS FOR DISEASE CONTROL AND PREVENTION
CDC INFLUENZA 2009 A(H1N1)PDM REAL-TIME RT-PCR PANEL
2010-06-22
CENTERS FOR DISEASE CONTROL AND PREVENTION
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT- PCR DETECTION AND CHARACTERIZATION PANEL
2008-09-30
CENTERS FOR DISEASE CONTROL AND PREVENTION
SYNTHETIC VDRL ANTIGEN
2000-02-23
CENTERS FOR DISEASE CONTROL AND PREVENTION
SERA FOR ANTINUCLEAR ANTIBODIES
1982-10-26
CENTERS FOR DISEASE CONTROL AND PREVENTION
LEGIONELLA DIRECT FLUORESCENT ANTIBODY
1981-09-08
CENTERS FOR DISEASE CONTROL AND PREVENTION
LEGIONELLA INDIRECT FLUOR. ANTIBODY
1981-09-08
CENTERS FOR DISEASE CONTROL AND PREVENTION