Cepheid Ab

FDA Filings

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

FDA Registration(s)
Registration Number3009613136
FEI Number3009613136
NameCEPHEID AB
Owner & OperatorCEPHEID
Contact Address904 CARIBBEAN DRIVE --
Sunnyvale CA 94089 US
Official Correspondent
  • Yi-Ping Lin
  • x-978-3179606-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressR?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)

FDA Filings

Device
Company
DeviceDate
CEPHEID AB [CEPHEID]
Xpert Vaginal/Endocervical Specimen Collection Kit2019-05-23
CEPHEID AB [CEPHEID]
Xpert Urine Specimen Collection Kit2019-05-23
CEPHEID AB [CEPHEID]
Xpert Swab Specimen Collection Kit2019-05-23
CEPHEID AB [CEPHEID]
Xpert CT/NG2019-05-23
CEPHEID AB [CEPHEID]
Xpert Vaginal/Endocervical Specimen Collection Kit2019-05-23
CEPHEID AB [CEPHEID]
Xpert Urine Specimen Collection Kit2019-05-23
CEPHEID AB [CEPHEID]
Xpert Swab Specimen Collection Kit2019-05-23
CEPHEID AB [CEPHEID]
Xpert CT/NG2019-05-23
CEPHEID AB [CEPHEID]
Xpert Vaginal/Endocervical Specimen Collection Kit2019-05-23
CEPHEID AB [CEPHEID]
Xpert Urine Specimen Collection Kit2019-05-23
CEPHEID AB [CEPHEID]
Xpert Swab Specimen Collection Kit2019-05-23
CEPHEID AB [CEPHEID]
Xpert CT/NG2019-05-23
CEPHEID AB [CEPHEID]
Xpert Vaginal/Endocervical Specimen Collection Kit2019-05-23
CEPHEID AB [CEPHEID]
Xpert Urine Specimen Collection Kit2019-05-23
CEPHEID AB [CEPHEID]
Xpert Swab Specimen Collection Kit2019-05-23
CEPHEID AB [CEPHEID]
Xpert CT/NG2019-05-23
CEPHEID AB [CEPHEID]
Xpert Xpress Flu2017-02-15
CEPHEID AB [CEPHEID]
Xpert Xpress Flu/RSV2017-02-15
CEPHEID AB [CEPHEID]
Xpert SA Nasal Comp Elution Reagent 700-51972013-11-12
CEPHEID AB [CEPHEID]
Xpert Norovirus Sample Reagent 700-56662013-11-12
CEPHEID AB [CEPHEID]
Xpert MTB/RIF Sample Reagent 700-52082013-11-12
CEPHEID AB [CEPHEID]
Xpert MRSA/SA Elution Reagent 700-51942013-11-12
CEPHEID AB [CEPHEID]
Xpert MRSA NxG Elution Reagent 700-52802013-11-12
CEPHEID AB [CEPHEID]
Xpert MRSA Elution Reagent 700-53752013-11-12
CEPHEID AB [CEPHEID]
Xpert C difficile/Epi Sample Reagent 700-56672013-11-12
CEPHEID AB [CEPHEID]
Xpert C difficile Sample Reagent 700-51962013-11-12
CEPHEID AB [CEPHEID]
SmartMix HM2013-11-12
CEPHEID AB [CEPHEID]
SmartMix HM Reagent2013-11-12
CEPHEID AB [CEPHEID]
OMNIMIX HS2013-11-12

Related Finance Registrations
NCAGE CodeAB47NCEPHEID AB
NCAGE CodeSWC82CEPHEID AB
CAGE CodeSWC82CEPHEID AB
CAGE CodeAB47NCEPHEID AB
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2019122110290Stockholm,Sweden -> Oakland, CaliforniaWATER, BULK, MOLECULAR BIOLOGY GRADE 150 L/EACH H.S.CODE: 30049099 HTS: 2853.90.909016 PKG
201909044366Anvers,Belgium -> Oakland, CaliforniaPLASTIC BOXES23 PKG
201909044366Anvers,Belgium -> Oakland, CaliforniaPLASTIC BOXES23 PKG
2018121922316Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyGUAIDINE THIOCYANATE UN 1759 CLASS 8 PG III NON STACKABLE HS-CODE 2926200020 PKG
2018121433989Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyGUAIDINE THIOCYANATE UN 1759 CLASS 8 PG III NON STACKABLE HS-CODE 2926200020 PKG
201802231915Stadersand,Federal Republic of Germany -> Oakland, CaliforniaCORROSIVE SOLID15 PKG
201802213889Stadersand,Federal Republic of Germany -> Oakland, CaliforniaCORROSIVE SOLID15 PKG
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