FDA.reportPublic FDA data

Life Technologies Corporation

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
13172681317268Life Technologies Corporation1N2026-01-013175 STALEY ROAD GRAND ISLAND NY US 14072
30033350803003335080Life Technologies Corporation1Y2026-01-017335 Executive Way FREDERICK MD US 21704
30072871523007287152LIFE TECHNOLOGIES CORPORATION1N2026-01-015781 Van Allen Way Carlsbad CA US 92008
30092076313009207631LIFE TECHNOLOGIES CORPORATION1N2026-01-012130 Woodward St Austin TX US 78744
30099764203009976420LIFE TECHNOLOGIES CORPORATION1N2026-01-016055 Sunol Blvd Pleasanton CA US 94566
30102860733010286073LIFE TECHNOLOGIES HOLDINGS PTE LTD1N2026-01-017 Gul Circle, #2M-01/08 Keppel Logistics Building Jurong West North West SG 629563
30111043813011104381LIFE TECHNOLOGIES CORPORATION1N2026-01-01180 Oyster Point Blvd S San Fran CA US 94080
30155290003015529000LIFE TECHNOLOGIES CORPORATION1N2026-01-01246 Goose Lane Suite 100 Guilford CT US 06437
80404703003312338Life Technologies LTD.1N2020-04-253 FOUNTAIN DR. INCHINNAN BUSINESS PARK PAISLEY, SCOTLAND Scotland GB PA4 9RF

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2001651744701508P240040Oncomine Dx Express TestPQP2025-07-02
270991744701508P240040Oncomine Dx Express TestPQP2025-07-02
2001611744701508P240040Oncomine Dx Express TestPQP2025-07-02
2001611800022958P160045Oncomine Dx Target TestPQP2017-06-22
270991800022958P160045Oncomine Dx Target TestPQP2017-06-22
1769151800022958P160045Oncomine Dx Target TestPQP2017-06-22
270991604175052K990641CALTAG FETAL HEMOGLOBIN TESTGHQ1999-09-17
270991350169827K963954CD 19 R-PE, CD19 TRI-COLOR MONOCLONAL ANTIBODYGKZ1996-11-25
270991960508247K951073CD3 TRI-COLOR/CD4 R-PE/CD8 FITC MONOCLONAL ANTIBODY COMBINATIONGKZ1995-12-21
270991035124307K944128CALTAG CD4 R-PE MONOCLONAL ANTIBODYGKZ1995-06-20
270991287992234K944127CALTAG CD3 FITC, R-PE, TRI-COLOR MONOCLONAL ANTIBODYGKZ1995-06-20
270991069100597K944126CALTAG CD8 FITC AND CD8 R-PE MONOCLONAL ANTIBODIESGKZ1995-06-20
2001651289469316K241806Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select PanelQOF2025-01-08
1769151289469316K241806Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select PanelQOF2025-01-08
1769152050389085K233453Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR KitQQX2024-07-10
271001671917395K113566OPTMIZER CTS T-CELL EXPANSION SERUM FREE MEDIUMNDS2012-06-21
271001635731929K103302STEMPRO MSC SFMNDS2011-02-18
271001318700673K100616KNOCKOUT SR MEDIUM, KNOCKOUT SR XENOFREE MEDIUM MODEL 10828, 12618NDS2010-05-20
271002051075307K022086AIM-V (R) MEDIUM, MODEL 087-0112NDS2002-12-23
270991186822089DEN130018CYTOSCAN(R) DXPFX2014-01-17
271001354339323DEN000008DULBECCO'S MODIFIED EAGLE MEDIUM (DMEM)NDS2001-02-16
2001651439742647BK110039
271001299302735
270941299302735
271001435694588
270941435694588
270991476443935
270941670568489
271001847737022
270942068130628
271002068130628
270991056825857
1594441074170264
270991171575359
270991296679319
2001611296679319
270991385745925
2307321430565384
2001651430565384
2001611430565384
270991430565384
1617611430565384
1594441447321233
270991484503019
1617611582680989
2001611582680989
270991582680989
2307321582680989
271001670568489
1769151723986161
1617611723986161
2001651723986161
270991723986161
270991972945169
1617611972945169
270991990123005

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NDS52012-06-21
GKZ51996-11-25
PQP32017-06-22
QOF22025-01-08
QQX12024-07-10
PFX12014-01-17
GHQ11999-09-17

PMA#

Oncomine Dx Target Test

2023-02-01

LIFE TECHNOLOGIES CORPORATION5781 Van Allen Waycarlsbad, CA 92008 PMA NumberP160045 Supplement NumberS038 Date Received08/05/2022 Decision Date02/01/2023 Product Code PQP  Advisory Committee Pathology Clinical TrialsNCT02609776 Supplement Typenormal 180 Day...

Oncomine Dx Target Test

2022-09-19

LIFE TECHNOLOGIES CORPORATION5781 Van Allen Waycarlsbad, CA 92008 PMA NumberP160045 Supplement NumberS037 Date Received06/14/2022 Decision Date09/19/2022 Product Code PQP  Advisory Committee Pathology Supplement Typereal-time Process Supplement Reason Chang...

Oncomine Dx Target Test

2022-08-11

LIFE TECHNOLOGIES CORPORATION5781 Van Allen Waycarlsbad, CA 92008 PMA NumberP160045 Supplement NumberS035 Date Received03/08/2022 Decision Date08/11/2022 Product Code PQP  Advisory Committee Pathology Clinical TrialsNCT03505710 Supplement Typepanel Track Su...

Oncomine Dx Target Test

2022-08-11

LIFE TECHNOLOGIES CORPORATION5781 Van Allen Waycarlsbad, CA 92008 PMA NumberP160045 Supplement NumberS036 Date Received03/29/2022 Decision Date08/11/2022 Product Code PQP  Advisory Committee Pathology Supplement Type135 Review Track For 30-day Notice Supple...

PMN#

GUDID#

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