Cepheid

FDA Filings

This page includes the latest FDA filings for Cepheid. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Cepheid holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

CEPHEID AB

FDA Registration(s)

Registration Number	3009613136
FEI Number	3009613136
Name	CEPHEID AB
Owner & Operator	CEPHEID
Contact Address	904 CARIBBEAN DRIVE -- Sunnyvale CA 94089 US
Official Correspondent	Yi-Ping Lin x-978-3179606-x
US Agent	YI-PING LIN CEPHEID 978 3179606 yi-ping.lin@cepheid.com
Registration Status	1
Initial Importer	N
Registration Expiration	2020-04-25
Registration Address	R?ntgenvagen 5 SOLNA Stockholms lan [SE-01], SE-171 54 SE
Establishment Type	Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device for Another Party (Contract Manufacturer)

Registration Number	3004530258
FEI Number	3004530258
Name	CEPHEID
Owner & Operator	CEPHEID
Contact Address	904 CARIBBEAN DRIVE -- Sunnyvale CA 94089 US
Official Correspondent	Yi-Ping Lin x-978-3179606-x
Registration Status	1
Initial Importer	N
Registration Expiration	2020-04-25
Registration Address	904 CARIBBEAN DRIVE Sunnyvale, CA 94089 US
Establishment Type	Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Device in the United States for Export Only

FDA Filings

Device Company	Device	Date
GUDID 07332940009366 CEPHEID	GeneXpert® GXHCV-10	2024-07-30
GUDID 07332940008161 CEPHEID	GeneXpert® XPRSGBS-10	2024-02-26
GUDID 07332940008581 CEPHEID	GeneXpert® XPRS-COV2-10	2024-01-30
GUDID 07332940009243 CEPHEID	GeneXpert® Xpress GX-IV Xpress	2023-10-30
GUDID 07332940008604 CEPHEID	GeneXpert® XPRS4PLEX-10	2023-10-03
GUDID 07332940007669 CEPHEID	Xpert® GXGBSLBXC-120	2022-08-08
GUDID 07332940007652 CEPHEID	Xpert® GXGBSLBXC-10	2022-08-08
GUDID 07332940007195 CEPHEID	GeneXpert® 900-0828	2022-05-20
GUDID 07332940007720 CEPHEID	GeneXpert® GX-INFINITY 80	2022-05-11
GUDID 07332940007713 CEPHEID	GeneXpert® GX-INFINITY 48S	2022-05-11
GUDID 07332940007706 CEPHEID	GeneXpert® GX-XVI R2	2022-05-11
GUDID 07332940007690 CEPHEID	GeneXpert® GX-IV R2	2022-05-11
GUDID 07332940007683 CEPHEID	GeneXpert® GX-II R2	2022-05-11
GUDID 07332940006457 CEPHEID	Xpert® SWAB/F-100	2022-05-11
PMN K203429 Cepheid	Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System	2022-05-09
GUDID 07332940007072 CEPHEID	Xpert® XPRSMVP-10	2022-04-21
GUDID 07332940008345 CEPHEID	Xpert® SWAB/G-50-US	2022-04-20
PMN K212213 Cepheid	Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System	2022-02-09
PEU CEPHEID	Xpert MTB/RIF	2020-03-04
OUY CEPHEID	Xpert TV	2020-03-04
OCC CEPHEID	Xpert Flu	2020-03-04
NIA CEPHEID	Xpert Flu/RSV XC	2020-03-04
MKZ CEPHEID	Xpert CT/NG	2020-03-04
LSL CEPHEID	Xpert CT/NG	2020-03-04
OOI CEPHEID	GeneXpert Edge System (For Export Only)	2019-12-14
GUDID 07332940007102 CEPHEID	Xpert BCR-ABL Ultra GXBCRABL-US-10	2019-11-04
GUDID 07332940007003 CEPHEID	Xpert Swab Specimen Collection Kit SWAB/G-50	2019-11-04
GUDID 07332940006815 CEPHEID	GeneXpert Dx System 900-0425	2019-10-25
GUDID 07332940006761 CEPHEID	GeneXpert Dx System 900-0398	2019-10-25
GUDID 07332940006754 CEPHEID	GeneXpert Dx System 900-0397	2019-10-25
GUDID 07332940006747 CEPHEID	GeneXpert Dx System 900-0395	2019-10-25
GUDID 07332940006730 CEPHEID	GeneXpert Dx System 900-0391	2019-10-25
GUDID 07332940006723 CEPHEID	GeneXpert Dx System 900-0144	2019-10-25
GUDID 07332940006716 CEPHEID	GeneXpert Dx System 900-0141	2019-10-25
GUDID 07332940004408 CEPHEID	Certified Pre-Owned GeneXpert Dx System 900-0518R	2019-10-25
GUDID 07332940004392 CEPHEID	Certified Pre-Owned GeneXpert Dx System 900-0519R	2019-10-25
GUDID 07332940004385 CEPHEID	Certified Pre-Owned GeneXpert Dx System 900-0520R	2019-10-25
GUDID 07332940004378 CEPHEID	Certified Pre-Owned GeneXpert Dx System 900-0521R	2019-10-25
GUDID 07332940004361 CEPHEID	GeneXpert Dx System 900-0523	2019-10-25
GUDID 07332940004309 CEPHEID	GeneXpert Dx System 900-0542	2019-10-25
GUDID 07332940004194 CEPHEID	GeneXpert Dx System 900-0423	2019-10-25
GUDID 07332940004170 CEPHEID	GeneXpert Dx System 900-0424	2019-10-25
GUDID 07332940004156 CEPHEID	GeneXpert Dx System 900-0427	2019-10-25
GUDID 07332940004149 CEPHEID	GeneXpert Dx System 900-0428	2019-10-25
GUDID 07332940004132 CEPHEID	GeneXpert Dx System 900-0429	2019-10-25
GUDID 07332940004071 CEPHEID	GeneXpert Dx System 900-0381	2019-10-25
GUDID 07332940004057 CEPHEID	GeneXpert Dx System 900-0392	2019-10-25
GUDID 07332940004040 CEPHEID	GeneXpert Dx System 900-0393	2019-10-25
GUDID 07332940004033 CEPHEID	GeneXpert Dx System 900-0400	2019-10-25
GUDID 07332940003951 CEPHEID	Certified Pre-Owned GeneXpert Dx System 900-0505R	2019-10-25
GUDID 07332940003937 CEPHEID	Certified Pre-Owned GeneXpert Dx System 900-0510R	2019-10-25
GUDID 07332940003920 CEPHEID	Certified Pre-Owned GeneXpert Dx System 900-0511R	2019-10-25
GUDID 07332940003913 CEPHEID	Certified Pre-Owned GeneXpert Dx System 900-0512R	2019-10-25
GUDID 07332940003890 CEPHEID	Certified Pre-Owned GeneXpert Dx System 900-0513R	2019-10-25
GUDID 07332940003852 CEPHEID	Certified Pre-Owned GeneXpert Dx System 900-0485R	2019-10-25
GUDID 07332940003449 CEPHEID	GeneXpert Dx System 900-0065	2019-10-25
GUDID 07332940003388 CEPHEID	GeneXpert Dx System 900-0138	2019-10-25
GUDID 07332940003371 CEPHEID	GeneXpert Dx System 900-0140	2019-10-25
GUDID 07332940003364 CEPHEID	GeneXpert Dx System 900-0145	2019-10-25
GUDID 07332940003357 CEPHEID	GeneXpert Dx System 900-0146	2019-10-25
GUDID 07332940001483 CEPHEID	GeneXpert Dx System 900-0521	2019-10-25
GUDID 07332940001476 CEPHEID	GeneXpert Dx System 900-0520	2019-10-25
GUDID 07332940001469 CEPHEID	GeneXpert Dx System 900-0519	2019-10-25
GUDID 07332940001452 CEPHEID	GeneXpert Dx System 900-0518	2019-10-25
GUDID 07332940001445 CEPHEID	GeneXpert Dx System 900-0512	2019-10-25
GUDID 07332940001438 CEPHEID	GeneXpert Dx System 900-0511	2019-10-25
GUDID 07332940001421 CEPHEID	GeneXpert Dx System 900-0510	2019-10-25
GUDID 07332940001414 CEPHEID	GeneXpert Dx System 900-0505	2019-10-25
GUDID 07332940001384 CEPHEID	GeneXpert Dx System 900-0513	2019-10-25
GUDID 07332940001377 CEPHEID	GeneXpert Dx System 900-0485	2019-10-25
GUDID 07332940001360 CEPHEID	GeneXpert Dx System 900-0490	2019-10-25
PMN K190076 \| OYX CEPHEID	Xpert BCR-ABL Ultra	2019-10-10
PMN K190076 \| OOI CEPHEID	Xpert BCR-ABL Ultra	2019-10-10
PMN K190076 Cepheid	Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s And GeneXpert Infinity-80 Systems	2019-09-27
PMN K190441 Cepheid	Xpert CT/NG, GeneXpert Dx System, GeneXpert Infinity-48s And GeneXpert Infinity-80 Systems, GeneXpert Infinity-48 System, Xpert Vaginal/Endocervical Specimen Collection, Xpert Urine Specimen Collection Kit, Xpert Swab Specimen Collection Kit	2019-05-23
PMN K190441 \| QEP CEPHEID	Xpert Vaginal/Endocervical Specimen Collection Kit	2019-05-23
PMN K190441 \| QEP CEPHEID	Xpert Urine Specimen Collection Kit	2019-05-23
PMN K190441 \| QEP CEPHEID	Xpert Swab Specimen Collection Kit	2019-05-23
PMN K190441 \| QEP CEPHEID	Xpert CT/NG	2019-05-23
PMN K190441 \| QEP CEPHEID AB [CEPHEID]	Xpert Vaginal/Endocervical Specimen Collection Kit	2019-05-23
PMN K190441 \| QEP CEPHEID AB [CEPHEID]	Xpert Urine Specimen Collection Kit	2019-05-23
PMN K190441 \| QEP CEPHEID AB [CEPHEID]	Xpert Swab Specimen Collection Kit	2019-05-23
PMN K190441 \| QEP CEPHEID AB [CEPHEID]	Xpert CT/NG	2019-05-23
PMN K190441 \| QBD CEPHEID	Xpert Vaginal/Endocervical Specimen Collection Kit	2019-05-23
PMN K190441 \| QBD CEPHEID	Xpert Urine Specimen Collection Kit	2019-05-23
PMN K190441 \| QBD CEPHEID	Xpert Swab Specimen Collection Kit	2019-05-23
PMN K190441 \| QBD CEPHEID	Xpert CT/NG	2019-05-23
PMN K190441 \| QBD CEPHEID AB [CEPHEID]	Xpert Vaginal/Endocervical Specimen Collection Kit	2019-05-23
PMN K190441 \| QBD CEPHEID AB [CEPHEID]	Xpert Urine Specimen Collection Kit	2019-05-23
PMN K190441 \| QBD CEPHEID AB [CEPHEID]	Xpert Swab Specimen Collection Kit	2019-05-23
PMN K190441 \| QBD CEPHEID AB [CEPHEID]	Xpert CT/NG	2019-05-23
PMN K190441 \| MKZ CEPHEID	Xpert Vaginal/Endocervical Specimen Collection Kit	2019-05-23
PMN K190441 \| MKZ CEPHEID	Xpert Urine Specimen Collection Kit	2019-05-23
PMN K190441 \| MKZ CEPHEID	Xpert Swab Specimen Collection Kit	2019-05-23
PMN K190441 \| MKZ CEPHEID	Xpert CT/NG	2019-05-23
PMN K190441 \| MKZ CEPHEID AB [CEPHEID]	Xpert Vaginal/Endocervical Specimen Collection Kit	2019-05-23
PMN K190441 \| MKZ CEPHEID AB [CEPHEID]	Xpert Urine Specimen Collection Kit	2019-05-23
PMN K190441 \| MKZ CEPHEID AB [CEPHEID]	Xpert Swab Specimen Collection Kit	2019-05-23
PMN K190441 \| MKZ CEPHEID AB [CEPHEID]	Xpert CT/NG	2019-05-23
PMN K190441 \| LSL CEPHEID	Xpert Vaginal/Endocervical Specimen Collection Kit	2019-05-23
PMN K190441 \| LSL CEPHEID	Xpert Urine Specimen Collection Kit	2019-05-23
PMN K190441 \| LSL CEPHEID	Xpert Swab Specimen Collection Kit	2019-05-23
PMN K190441 \| LSL CEPHEID	Xpert CT/NG	2019-05-23
PMN K190441 \| LSL CEPHEID AB [CEPHEID]	Xpert Vaginal/Endocervical Specimen Collection Kit	2019-05-23
PMN K190441 \| LSL CEPHEID AB [CEPHEID]	Xpert Urine Specimen Collection Kit	2019-05-23
PMN K190441 \| LSL CEPHEID AB [CEPHEID]	Xpert Swab Specimen Collection Kit	2019-05-23
PMN K190441 \| LSL CEPHEID AB [CEPHEID]	Xpert CT/NG	2019-05-23
PMN K190771 Cepheid	Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System	2019-04-25
GUDID 07332940002442 CEPHEID	Xpert MRSA GXMRSA-120	2019-01-23
GUDID 07332940001728 CEPHEID	Xpert MRSA NxG GXMRSA-NXG-120	2019-01-23
GUDID 07332940001711 CEPHEID	Xpert MRSA NxG GXMRSA-NXG-10	2019-01-23
GUDID 07332940001032 CEPHEID	Xpert Carba-R GXCARBAR-10	2019-01-23
GUDID 07332940000233 CEPHEID	Xpert vanA GXVANA-10	2019-01-23
GUDID 07332940000196 CEPHEID	Xpert MRSA GXMRSA-100N-10	2019-01-23
PMN K181289 Cepheid	Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48S System And GeneXpert Infinity-80 System	2018-08-15
GUDID 07332940004910 CEPHEID	SmartCycler Dx System SC2500N17-1	2018-08-03
GUDID 07332940004903 CEPHEID	SmartCycler Dx System SC2500N18-1	2018-08-03
GUDID 07332940004880 CEPHEID	SmartCycler Dx System SC2500N19-1	2018-08-03
GUDID 07332940004767 CEPHEID	SmartCycler Dx System SC2500N5-1	2018-08-03
GUDID 07332940004606 CEPHEID	SmartCycler Dx System SC2500N1-1	2018-08-03
GUDID 07332940004583 CEPHEID	SmartCycler Dx System SC2500N12-1	2018-08-03
GUDID 07332940004569 CEPHEID	SmartCycler Dx System SC2500N13-1	2018-08-03
GUDID 07332940004545 CEPHEID	SmartCycler Dx System SC2500N14-1	2018-08-03
GUDID 07332940004538 CEPHEID	SmartCycler Dx System SC2500N15-1	2018-08-03
GUDID 07332940004521 CEPHEID	SmartCycler Dx System SC2500N16-1	2018-08-03
GUDID 07332940002954 CEPHEID	Xpert Urine Specimen Collection Kit URINE/A-50	2018-08-02
GUDID 07332940002565 CEPHEID	Xpert Nasopharyngeal Sample Collection Kit SWAB/B-100	2018-08-02
GUDID 07332940002558 CEPHEID	Xpert Vaginal/Endocervical Specimen Collection Kit SWAB/A-50	2018-08-02
GUDID 07332940001872 CEPHEID	Xpert Check XPERTCHECK-US-5	2018-08-02
GUDID 07332940002503 CEPHEID	Xpert Xpress Strep A XPRSTREPA-120	2018-07-30
PMN K180218 Cepheid	Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV	2018-07-24
GUDID 07332940006709 CEPHEID	GeneXpert Dx System 900-0139	2018-07-18
GUDID 07332940004163 CEPHEID	GeneXpert Dx System 900-0426	2018-07-18
GUDID 07332940004125 CEPHEID	GeneXpert Dx System 900-0433	2018-07-18
GUDID 07332940000806 CEPHEID	Xpert GBS LB GXGBS-LB-120	2018-07-06
GUDID 07332940000783 CEPHEID	Xpert FLU/RSV XC GXFLU/RSV-10	2018-07-06
GUDID 07332940000240 CEPHEID	Xpert Factor II & Factor V GXFIIFV-10	2018-07-06
GUDID 07332940000189 CEPHEID	Xpert MRSA/SA SSTI GXMRSA/SA-SSTI-10	2018-07-06
GUDID 07332940000165 CEPHEID	Xpert SA Nasal Complete GXSACOMP-120	2018-07-06
GUDID 07332940000158 CEPHEID	Xpert SA Nasal Complete GXSACOMP-10	2018-07-06
GUDID 07332940000141 CEPHEID	Xpert MRSA/SA Blood Culture GXMRSA/SA-BC-10	2018-07-06
GUDID 07332940000127 CEPHEID	Xpert GBS GXGBS-100N-10	2018-07-06
GUDID 07332940000097 CEPHEID	Xpert EV GXEV-100N-10	2018-07-06
GUDID 07332940000080 CEPHEID	Xpert CT/NG GXCT/NG-10	2018-07-06
GUDID 07332940000059 CEPHEID	Xpert C. difficile GXCDIFFICILE-120	2018-07-06
GUDID 07332940000042 CEPHEID	Xpert C. difficile/Epi GXCDIFF/EPI-120	2018-07-06
GUDID 07332940000035 CEPHEID	Xpert C. difficile GXCDIFFICILE-10	2018-07-06
GUDID 07332940000028 CEPHEID	Xpert C. difficile/Epi GXCDIFF/EPI-10	2018-07-06
PMN K173840 \| OOI CEPHEID	Xpert Vaginal/Endocervical Specimen Collection Kit	2018-05-21
PMN K173840 \| OOI CEPHEID	Xpert Urine Specimen Collection Kit	2018-05-21
PMN K173840 \| OOI CEPHEID	Xpert CT/NG	2018-05-21
PMN K173840 \| MKZ CEPHEID	Xpert Vaginal/Endocervical Specimen Collection Kit	2018-05-21
PMN K173840 \| MKZ CEPHEID	Xpert Urine Specimen Collection Kit	2018-05-21
PMN K173840 \| MKZ CEPHEID	Xpert CT/NG	2018-05-21
PMN K173840 \| LSL CEPHEID	Xpert Vaginal/Endocervical Specimen Collection Kit	2018-05-21
PMN K173840 \| LSL CEPHEID	Xpert Urine Specimen Collection Kit	2018-05-21
PMN K173840 \| LSL CEPHEID	Xpert CT/NG	2018-05-21
PMN K173840 \| LIO CEPHEID	Xpert Vaginal/Endocervical Specimen Collection Kit	2018-05-21
PMN K173840 \| LIO CEPHEID	Xpert Urine Specimen Collection Kit	2018-05-21
PMN K173840 \| LIO CEPHEID	Xpert CT/NG	2018-05-21
PMN K173398 Cepheid	Xpert Xpress Strep A	2018-04-26
PMN K173840 Cepheid	Xpert CT/NG	2018-03-16
PMN K173263 \| POC CEPHEID	Xpert Carba-R	2018-01-16
PMN K173263 \| POC CEPHEID	GeneXpert Infinity-80	2018-01-16
PMN K173263 \| POC CEPHEID	GeneXpert Infinity-48s	2018-01-16
PMN K173263 \| POC CEPHEID	GeneXpert Infinity-48	2018-01-16
PMN K173263 \| POC CEPHEID	GeneXpert Dx	2018-01-16
PMN K173263 \| PMY CEPHEID	Xpert Carba-R	2018-01-16
PMN K173263 \| PMY CEPHEID	GeneXpert Infinity-80	2018-01-16
PMN K173263 \| PMY CEPHEID	GeneXpert Infinity-48s	2018-01-16
PMN K173263 \| PMY CEPHEID	GeneXpert Infinity-48	2018-01-16
PMN K173263 \| PMY CEPHEID	GeneXpert Dx	2018-01-16
PMN K173263 \| OOI CEPHEID	Xpert Carba-R	2018-01-16
PMN K173263 \| OOI CEPHEID	GeneXpert Infinity-80	2018-01-16
PMN K173263 \| OOI CEPHEID	GeneXpert Infinity-48s	2018-01-16
PMN K173263 \| OOI CEPHEID	GeneXpert Infinity-48	2018-01-16
PMN K173263 \| OOI CEPHEID	GeneXpert Dx	2018-01-16
PMN K173263 Cepheid	Xpert Carba-R	2018-01-09
PMN K171552 \| OOI CEPHEID	Xpert Nasopharyngeal Sample Collection Kit	2018-01-03
PMN K171552 \| OOI CEPHEID	Xpert Nasal Sample Collection Kit	2018-01-03
PMN K171552 \| OOI CEPHEID	GeneXpert Xpress System	2018-01-03
PMN K171552 \| OCC CEPHEID	Xpert Nasopharyngeal Sample Collection Kit	2018-01-03
PMN K171552 \| OCC CEPHEID	Xpert Nasal Sample Collection Kit	2018-01-03
PMN K171552 \| OCC CEPHEID	GeneXpert Xpress System	2018-01-03
PMN K171552 \| JSM CEPHEID	Xpert Nasopharyngeal Sample Collection Kit	2018-01-03
PMN K171552 \| JSM CEPHEID	Xpert Nasal Sample Collection Kit	2018-01-03
PMN K171552 \| JSM CEPHEID	GeneXpert Xpress System	2018-01-03
PMN K171552 Cepheid	Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV	2017-12-19
PMN K172126 \| PGX CEPHEID	Xpert Xpress Strep A	2017-09-26
PMN K172126 \| OOI CEPHEID	Xpert Xpress Strep A	2017-09-26
PMN K172126 Cepheid	Xpert Xpress Strep A	2017-09-25
PMN K162456 \| OCC CEPHEID	Xpert Xpress Flu	2017-02-15
PMN K162456 \| OCC CEPHEID AB [CEPHEID]	Xpert Xpress Flu	2017-02-15
PMN K162331 \| OCC CEPHEID	Xpert Xpress Flu/RSV	2017-02-15
PMN K162331 \| OCC CEPHEID AB [CEPHEID]	Xpert Xpress Flu/RSV	2017-02-15
PMN K162456 CEPHEID	Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48 System And GeneXpert Infinity-48s System, GeneXpert Infinity-80 System	2017-02-13
PMN K162331 CEPHEID	Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48 System And GeneXpert Infinity-48s System, GeneXpert Infinity-80 System	2017-02-09
PMN K162444 \| OOI CEPHEID	Xpert MRSA NxG	2016-11-29
PMN K162444 \| NQX CEPHEID	Xpert MRSA NxG	2016-11-29
PMN K162444 CEPHEID	Xpert MRSA NxG	2016-11-23
PMN K161619 Cepheid	Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48, Genxpert Infinity-48s And GeneXpert Infinity-80 Systems	2016-08-29
PMN K160901 CEPHEID	Xpert Carba-R	2016-06-29
PMN K152614 CEPHEID	Xpert Carba-R	2016-03-07
PMN K151226 \| OOI CEPHEID	Xpert Nasopharyngeal Sample Collection Kit	2015-12-10
PMN K151226 \| OCC CEPHEID	Xpert Nasopharyngeal Sample Collection Kit	2015-12-10
PMN K151226 \| JSM CEPHEID	Xpert Nasopharyngeal Sample Collection Kit	2015-12-10
PMN K151226 CEPHEID	Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Xpress System (GX-I)	2015-12-03
PMN K151565 \| OUY CEPHEID	Xpert TV	2015-11-10
PMN K151565 \| OOI CEPHEID	Xpert TV	2015-11-10
PMN K151565 CEPHEID	Xpert® TV Assay On The Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, And GeneXpertInfinity-80 Systems), Xpert Vaginal/Endocervical Specimen Collection Kit, And Xpert Urine Specimen Collection Kit	2015-10-16
LIB CEPHEID	Xpert Xpress Flu/RSV (For Export Only)	2015-06-05
LIB CEPHEID	Xpert Check (For Export Only)	2015-06-05
LIB CEPHEID	Xpert Carba-R (For Export Only)	2015-06-05
LIB CEPHEID	Xpert Breast Cancer STRAT4 (For Export Only)	2015-06-05
LIB CEPHEID	Xpert Bladder Cancer Monitor (For Export Only)	2015-06-05
LIB CEPHEID	Xpert Bladder Cancer Detection (For Export Only)	2015-06-05
NIA CEPHEID	Xpert Flu/RSV XC (For Export Only)	2015-06-04
PMN K143302 CEPHEID	Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-80	2015-02-12
PMN K142501 \| PCH CEPHEID	Xpert Norovirus	2014-12-09
PMN K142045 \| OOI CEPHEID	Xpert Flu/RSV XC	2014-12-09
PMN K142045 \| OCC CEPHEID	Xpert Flu/RSV XC	2014-12-09
PMN K142501 CEPHEID	Xpert Norovirus, GeneXpert Dx Systems (GX-I, GX-11, GX-IV, GX-XVI), GeneXpert Infinity-48 System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System	2014-11-26
PMN K142045 CEPHEID	XPERT FLU/RSV XC ASSAY	2014-11-22
PEU CEPHEID	Xpert MTB/RIF Ultra (For Export Only)	2014-05-09
PEU CEPHEID	Xpert MTB/RIF (For Export Only)	2014-05-09
OYX CEPHEID	Xpert BCR-ABL Ultra	2014-05-09
OCC CEPHEID	Xpert Flu (For Export Only)	2014-05-09
MKZ CEPHEID	Xpert CT/NG (For Export Only)	2014-05-09
MKZ CEPHEID	Xpert CT (For Export Only)	2014-05-09
LSL CEPHEID	Xpert CT/NG (For Export Only)	2014-05-09
PMN DEN130032 \| PEU CEPHEID	Xpert MTB/RIF	2013-12-19
PMN K130894 \| NQX CEPHEID	Xpert MRSA/SA Blood Culure Assay	2013-11-13
PPM CEPHEID	Xpert SA Nasal Comp Elution Reagent 700-5197	2013-11-12
PPM CEPHEID	Xpert Norovirus Sample Reagent 700-5666	2013-11-12
PPM CEPHEID	Xpert MTB/RIF Sample Reagent 700-5208	2013-11-12
PPM CEPHEID	Xpert MRSA/SA Elution Reagent 700-5194	2013-11-12
PPM CEPHEID	Xpert MRSA NxG Elution Reagent 700-5280	2013-11-12
PPM CEPHEID	Xpert MRSA Elution Reagent 700-5375	2013-11-12
PPM CEPHEID	Xpert C difficile/Epi Sample Reagent 700-5667	2013-11-12
PPM CEPHEID	Xpert C difficile Sample Reagent 700-5196	2013-11-12
PPM CEPHEID	SmartMix HM	2013-11-12
PPM CEPHEID	SmartMix HM Reagent	2013-11-12
PPM CEPHEID	OMNIMIX HS	2013-11-12
PPM CEPHEID AB [CEPHEID]	Xpert SA Nasal Comp Elution Reagent 700-5197	2013-11-12
PPM CEPHEID AB [CEPHEID]	Xpert Norovirus Sample Reagent 700-5666	2013-11-12
PPM CEPHEID AB [CEPHEID]	Xpert MTB/RIF Sample Reagent 700-5208	2013-11-12
PPM CEPHEID AB [CEPHEID]	Xpert MRSA/SA Elution Reagent 700-5194	2013-11-12
PPM CEPHEID AB [CEPHEID]	Xpert MRSA NxG Elution Reagent 700-5280	2013-11-12
PPM CEPHEID AB [CEPHEID]	Xpert MRSA Elution Reagent 700-5375	2013-11-12
PPM CEPHEID AB [CEPHEID]	Xpert C difficile/Epi Sample Reagent 700-5667	2013-11-12
PPM CEPHEID AB [CEPHEID]	Xpert C difficile Sample Reagent 700-5196	2013-11-12
PPM CEPHEID AB [CEPHEID]	SmartMix HM	2013-11-12
PPM CEPHEID AB [CEPHEID]	SmartMix HM Reagent	2013-11-12
PPM CEPHEID AB [CEPHEID]	OMNIMIX HS	2013-11-12
De Novo DEN130032 CEPHEID	XPERT MTB/RIF ASSAY	2013-07-25
PMN K130894 CEPHEID	XPERT MRSA/SA BLOOD CULTURE ASSAY; GENEXPERT DX SYSTEMS (GX-I, GX-II, GX-IV, GX-XVI); GENEXPERT INFINITY-48 SYSTEM; GENE	2013-06-20
PMN K121710 \| OOI CEPHEID	Xpert CT/NG	2013-01-08
PMN K121710 \| MKZ CEPHEID	Xpert CT/NG	2013-01-08
PMN K121710 \| LSL CEPHEID	Xpert CT/NG	2013-01-08
PMN K121710 CEPHEID	XPERT CT/NG	2012-12-27
PMN K123191 CEPHEID	XPERT FLU	2012-12-21
OHQ CEPHEID	Xpert Check, XPERTCHECK-US-5	2012-12-11
OHQ CEPHEID	Xpert Check, XPERTCHECK-CE-5 (For Export Only)	2012-12-11
PMN K121539 \| OOI CEPHEID	Xpert GBS LB Assay	2012-12-07
PMN K121539 \| NJR CEPHEID	Xpert GBS LB Assay	2012-12-07
PMN K121539 CEPHEID	XPERT GBS LB GENEXPERT DX SYSTEMS (GX-I, GX-IV) GENEXPERT DX SYSTEMS (GX-XVI) GENEXPERT INFINITY-48 SYSTEM (900-XXXX)	2012-11-02
PMN K120911 CEPHEID	XPERT FLU GENEXPERT DX SYSTEMS (GX-I, GX-IV)	2012-05-18
PMN K110203 \| OMN CEPHEID	Xpert C.difficile / Epi	2011-12-01
PMN K103766 CEPHEID	XPERT FLU, GENEXPERT DX SYSTEMS, GENEXPERT INFINITY SYSTEM, GENEXPERT SYSTEM SOFTWARE VERISIONS 2.1 AND 4.0	2011-04-21
PMN K110203 CEPHEID	XPERT C. DIFFICLE/EPI ASSAY	2011-04-07
PMN K100822 \| OOI CEPHEID	Xpert SA Nasal Complete	2010-12-14
PMN K100822 \| NQX CEPHEID	Xpert SA Nasal Complete	2010-12-14
PMN K092953 \| OOI CEPHEID	Xpert vanA	2010-12-14
PMN K092953 \| NIJ CEPHEID	Xpert vanA	2010-12-14
PMN K101879 CEPHEID	XPERT MRSA/SA BC (BLOOD CULTURE) ASSAY MODEL GXMRSA/SA-BC-10	2010-07-28
PMN K100822 CEPHEID	XPERT MRSA/SA NASAL ASSAY	2010-06-01
PMN K092953 CEPHEID	XPERT VANA ASSAY	2009-12-17
PMN K091109 \| LLH CEPHEID	Xpert C.difficile Assay	2009-11-20
PMN K082118 \| OOI CEPHEID	Xpert HemosIL FII & FV Assay	2009-11-20
PMN K082118 \| OOI CEPHEID	Xpert Factor II & Factor V	2009-11-20
PMN K082118 \| NPR CEPHEID	Xpert HemosIL FII & FV Assay	2009-11-20
PMN K082118 \| NPR CEPHEID	Xpert Factor II & Factor V	2009-11-20
PMN K082118 \| NPQ CEPHEID	Xpert HemosIL FII & FV Assay	2009-11-20
PMN K082118 \| NPQ CEPHEID	Xpert Factor II & Factor V	2009-11-20
PMN K082118 CEPHEID	XPERT HEMOSIL FACTOR II & FACTOR V ASSAY	2009-09-18
PMN K091109 CEPHEID	XPERT C. DIFFICILE	2009-07-09
PMN K080837 \| NQX CEPHEID	Xpert MRSA/SA SSTI	2008-10-17
PMN K082140 CEPHEID	XPERT MRSA/SA BLOOD CULTURE ASSAY	2008-09-29
PMN K080837 CEPHEID	XPERT MRSA/SA SSTI ASSAY	2008-09-24
PMN DEN070004 \| OAI CEPHEID	XPERT EV	2007-06-08
PMN K070462 CEPHEID	XPERT MRSA	2007-04-17
De Novo DEN070004 CEPHEID	XPERT EV, MODEL GXEV-100N-10; GENEXPERT DX SYSTEM, MODELS P/N 900-0144, 900-0145, 900-0146, 900-0065	2007-03-16
PMN K062948 CEPHEID	SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B	2006-12-08
PMN K060540 CEPHEID	XPERT, GENEXPERT DX SYSTEM	2006-07-25
PMN K070462 \| NQX CEPHEID	XPERT MRSA	2006-04-25
MVU CEPHEID	Norovirus G2 Probe	2006-04-25
MVU CEPHEID	Norovirus G2 Primer Set	2006-04-25
MVU CEPHEID	Norovirus G1 Probe	2006-04-25
MVU CEPHEID	Norovirus G1 Primer Set	2006-04-25
MVU CEPHEID	HSV-2 Probe	2006-04-25
MVU CEPHEID	HSV-2 Primer Set	2006-04-25
MVU CEPHEID	HSV-1 Probe	2006-04-25
MVU CEPHEID	HSV-1 Primer Set	2006-04-25
MVU CEPHEID	Control, SSC	2006-04-25
MVU CEPHEID	Control, PRM/PRB CIC	2006-04-25
MVU CEPHEID	B. pertussis Probe	2006-04-25
MVU CEPHEID	B. pertussis Primer Set	2006-04-25
MVU CEPHEID	B. parapertussis Probe	2006-04-25
MVU CEPHEID	B. parapertussis Primer Set	2006-04-25
PMN K062948 \| NJR CEPHEID	SMARTCYCLER DX SYSTEM AND SOFTWARE	2004-04-13
PMN K060540 \| NJR CEPHEID	XPERT GBS	2004-04-13

Related Finance Registrations

NCAGE Code	07YE7	CEPHEID
CAGE Code	07YE7	CEPHEID
S.A.M. Registration	07YE7 [956711444]	CEPHEID
SEC	0001037760	CEPHEID of CALIFORNIA

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020081530511	Stadersand,Federal Republic of Germany -> Oakland, California	EV ASSAY ELUTION REAGENT YOUR ORDER NO. 4500068744 HS-CODE 300490 HBL BANQBRE4382701 NOT STACKABLE .	1 PKG
2020081427939	Stadersand,Federal Republic of Germany -> Oakland, California	EV ASSAY ELUTION REAGENT YOUR ORDER NO. 4500068744 HS-CODE 300490 HBL BANQBRE4382701 NOT STACKABLE .	1 PKG
202004094683	Stadersand,Federal Republic of Germany -> Oakland, California	WASH REAGENT = 80 CTNS. ON 4 PALLETS HS-CODE 300490 HBL BANQBRE4176863 . . .	80 CTN
202003234924	Stadersand,Federal Republic of Germany -> Oakland, California	SAMPLE MANUFACTURING EV ASSAY WASH REAGENT EV ASSAY BINDING REAGENT PACKING LIST 202000092 202000093 ORDER 4500064267 4500064266	96 CTN
202001285389	Stadersand,Federal Republic of Germany -> Oakland, California	SAMPLE MANUFACTURING EV ASSAY WASH REAGENT EV ASSAY BINDING REAGENT EV ASSAY ELUTION REAGENT PACKING LIST 201902071 ORDER 4500063144 4500063267	96 CTN
202001039337	Stadersand,Federal Republic of Germany -> Oakland, California	SAMPLE MANUFACTURING EV ASSAY WASH REAGENT EV ASSAY BINDING REAGENT EV ASSAY ELUTION REAGENT PACKING LIST 201902071 ORDER 4500060748 HS CODE 300490	2 PKG
2019122110290	Stockholm,Sweden -> Oakland, California	WATER, BULK, MOLECULAR BIOLOGY GRADE 150 L/EACH H.S.CODE: 30049099 HTS: 2853.90.9090	16 PKG
2019091313415	Stadersand,Federal Republic of Germany -> Oakland, California	SAMPLE MANUFACTURING EV ASSAY WASH REAGENT EV ASSAY BINDING REAGENT EV ASSAY ELUTION REAGENT PACKING LIST 201901398 ORDER 4500052246 4500052248, 4500051841	2 PKG