Oncomine Dx Target Test
LIFE TECHNOLOGIES CORPORATION
Life Technologies Corporation
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1317268 | 1317268 | Life Technologies Corporation | 1 | N | 2026-01-01 | 3175 STALEY ROAD GRAND ISLAND NY US 14072 |
| 3003335080 | 3003335080 | Life Technologies Corporation | 1 | Y | 2026-01-01 | 7335 Executive Way FREDERICK MD US 21704 |
| 3007287152 | 3007287152 | LIFE TECHNOLOGIES CORPORATION | 1 | N | 2026-01-01 | 5781 Van Allen Way Carlsbad CA US 92008 |
| 3009207631 | 3009207631 | LIFE TECHNOLOGIES CORPORATION | 1 | N | 2026-01-01 | 2130 Woodward St Austin TX US 78744 |
| 3009976420 | 3009976420 | LIFE TECHNOLOGIES CORPORATION | 1 | N | 2026-01-01 | 6055 Sunol Blvd Pleasanton CA US 94566 |
| 3011104381 | 3011104381 | LIFE TECHNOLOGIES CORPORATION | 1 | N | 2026-01-01 | 180 Oyster Point Blvd S San Fran CA US 94080 |
| 3015529000 | 3015529000 | LIFE TECHNOLOGIES CORPORATION | 1 | N | 2026-01-01 | 246 Goose Lane Suite 100 Guilford CT US 06437 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 200161 | 1744701508 | P240040 | Oncomine Dx Express Test | PQP | 2025-07-02 |
| 27099 | 1744701508 | P240040 | Oncomine Dx Express Test | PQP | 2025-07-02 |
| 200165 | 1744701508 | P240040 | Oncomine Dx Express Test | PQP | 2025-07-02 |
| 27099 | 1800022958 | P160045 | Oncomine Dx Target Test | PQP | 2017-06-22 |
| 176915 | 1800022958 | P160045 | Oncomine Dx Target Test | PQP | 2017-06-22 |
| 200161 | 1800022958 | P160045 | Oncomine Dx Target Test | PQP | 2017-06-22 |
| 27099 | 1604175052 | K990641 | CALTAG FETAL HEMOGLOBIN TEST | GHQ | 1999-09-17 |
| 27099 | 1350169827 | K963954 | CD 19 R-PE, CD19 TRI-COLOR MONOCLONAL ANTIBODY | GKZ | 1996-11-25 |
| 27099 | 1960508247 | K951073 | CD3 TRI-COLOR/CD4 R-PE/CD8 FITC MONOCLONAL ANTIBODY COMBINATION | GKZ | 1995-12-21 |
| 27099 | 1035124307 | K944128 | CALTAG CD4 R-PE MONOCLONAL ANTIBODY | GKZ | 1995-06-20 |
| 27099 | 1287992234 | K944127 | CALTAG CD3 FITC, R-PE, TRI-COLOR MONOCLONAL ANTIBODY | GKZ | 1995-06-20 |
| 27099 | 1069100597 | K944126 | CALTAG CD8 FITC AND CD8 R-PE MONOCLONAL ANTIBODIES | GKZ | 1995-06-20 |
| 176915 | 1289469316 | K241806 | Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel | QOF | 2025-01-08 |
| 200165 | 1289469316 | K241806 | Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel | QOF | 2025-01-08 |
| 176915 | 2050389085 | K233453 | Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Kit | QQX | 2024-07-10 |
| 27100 | 1671917395 | K113566 | OPTMIZER CTS T-CELL EXPANSION SERUM FREE MEDIUM | NDS | 2012-06-21 |
| 27100 | 1635731929 | K103302 | STEMPRO MSC SFM | NDS | 2011-02-18 |
| 27100 | 1318700673 | K100616 | KNOCKOUT SR MEDIUM, KNOCKOUT SR XENOFREE MEDIUM MODEL 10828, 12618 | NDS | 2010-05-20 |
| 27100 | 2051075307 | K022086 | AIM-V (R) MEDIUM, MODEL 087-0112 | NDS | 2002-12-23 |
| 27099 | 1186822089 | DEN130018 | CYTOSCAN(R) DX | PFX | 2014-01-17 |
| 27100 | 1354339323 | DEN000008 | DULBECCO'S MODIFIED EAGLE MEDIUM (DMEM) | NDS | 2001-02-16 |
| 200165 | 1439742647 | BK110039 | |||
| 27100 | 1299302735 | ||||
| 27100 | 1435694588 | ||||
| 27099 | 1476443935 | ||||
| 27100 | 1847737022 | ||||
| 27100 | 2068130628 | ||||
| 27099 | 1056825857 | ||||
| 27099 | 1171575359 | ||||
| 27099 | 1296679319 | ||||
| 200161 | 1296679319 | ||||
| 176915 | 1367050087 | ||||
| 27099 | 1385745925 | ||||
| 200165 | 1430565384 | ||||
| 230732 | 1430565384 | ||||
| 200161 | 1430565384 | ||||
| 27099 | 1430565384 | ||||
| 161761 | 1430565384 | ||||
| 27099 | 1484503019 | ||||
| 27099 | 1582680989 | ||||
| 200161 | 1582680989 | ||||
| 230732 | 1582680989 | ||||
| 161761 | 1582680989 | ||||
| 27100 | 1670568489 | ||||
| 200165 | 1723986161 | ||||
| 27099 | 1723986161 | ||||
| 176915 | 1723986161 | ||||
| 161761 | 1723986161 | ||||
| 27099 | 1972945169 | ||||
| 161761 | 1972945169 | ||||
| 27099 | 1990123005 |
Product Codes Associated With Registrations#
PMA#
Oncomine Dx Target Test
LIFE TECHNOLOGIES CORPORATION
Oncomine Dx Target Test
LIFE TECHNOLOGIES CORPORATION
Oncomine Dx Target Test
LIFE TECHNOLOGIES CORPORATION
Oncomine Dx Target Test
LIFE TECHNOLOGIES CORPORATION
Oncomine Dx Target Test
LIFE TECHNOLOGIES CORPORATION
Oncomine Dx Target Test
LIFE TECHNOLOGIES CORPORATION
Oncomine Dx Target Test
LIFE TECHNOLOGIES CORPORATION
Oncomine Dx Target Test
LIFE TECHNOLOGIES CORPORATION
Oncomine Dx Target Test
LIFE TECHNOLOGIES CORPORATION
Oncomine Dx Target Test
LIFE TECHNOLOGIES CORPORATION
Oncomine Dx Target Test
LIFE TECHNOLOGIES CORPORATION
Oncomine Dx Target Test
LIFE TECHNOLOGIES CORPORATION
Oncomine Dx Target Test
LIFE TECHNOLOGIES CORPORATION
Oncomine Dx Target
LIFE TECHNOLOGIES CORPORATION
Oncomine Dx Target Test
LIFE TECHNOLOGIES CORPORATION
Oncomine Dx Target Test
LIFE TECHNOLOGIES CORPORATION
Oncomine Dx Target Test
LIFE TECHNOLOGIES CORPORATION
Oncomine Dx Target Test
LIFE TECHNOLOGIES CORPORATION
Oncomine Dx Target Test
LIFE TECHNOLOGIES CORPORATION
Oncomine Dx Target Test
LIFE TECHNOLOGIES CORPORATION
PMN#
Applied Biosystems? TaqPath? COVID-19, Flu A, Flu B, RSV Select Panel
Life Technologies Corporation
Applied Biosystems? TaqPath? COVID-19 Diagnostic PCR Kit
Life Technologies Corporation
Applied Biosystems™ 3500 Dx Genetic Analyzer And Applied Biosystems™ 3500xL Dx Genetic Analyzer
Life Technologies Corporation
Ion PGM Dx System
LIFE TECHNOLOGIES CORPORATION
QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT
LIFE TECHNOLOGIES CORPORATION
Qualitative Test For HLA, Non-diagnostic
Life Technologies Corporation
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
Life Technologies Corporation
STEMPRO MSC SFM
LIFE TECHNOLOGIES CORPORATION
KNOCKOUT SR MEDIUM, KNOCKOUT SR XENOFREE MEDIUM MODEL 10828, 12618
LIFE TECHNOLOGIES CORPORATION
Qualitative Test For HLA, Non-diagnostic
Life Technologies Corporation
GUDID#
QuantStudio™ 7 Pro Dx Software, V3.0.0 - A54626
2022-09-12
appliedbiosystems QuantStudioTM 7 Pro Dx Software - A52649, V2.0.0
2022-05-02
QuantStudio™ 7 Pro Dx Software - A52015, V1.0.5
2021-12-10
Dulbecco's Phosphate Buffered Saline (D-PBS) - 14040141
2016-08-04
Dulbecco's Phosphate Buffered Saline (D-PBS) - 14190136
2016-08-01
Hanks' Balanced Salt Solution (HBSS) - 14025092
2016-08-04
Dulbecco's Phosphate Buffered Saline (D-PBS) - 14040133
2016-08-04
Hanks' Balanced Salt Solution (HBSS) - 14170112
2016-08-04
Hanks' Balanced Salt Solution (HBSS) - 14175095
2016-08-04
Hanks' Balanced Salt Solution (HBSS) - 14175079
2016-08-04
Dulbecco's Phosphate Buffered Saline (D-PBS) - 14200075
2016-08-04
Hanks' Balanced Salt Solution (HBSS) - 24020117
2016-08-04
Dulbecco's Phosphate Buffered Saline (D-PBS) - 14040117
2016-08-01
Dulbecco's Phosphate Buffered Saline (D-PBS) - 14190144
2016-08-01
Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Control Dilution Buffer - Part 3 of 3 of TaqPath™ COVID-19 Diagnostic PCR Kit REF A58505
2025-02-17
TaqPath™ COVID-19, Flu A, Flu B, RSV Select Assay - Component 1 of 4 of A56123 (Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel)
2025-02-17
TaqPath™ COVID-19, Flu A, Flu B, RSV Select Positive Control - Component 2 of 4 of A56123 (Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel)
2025-02-17
TaqPath™ COVID-19, Flu A, Flu B, RSV Select Negative Control - Component 3 of 4 of A56123 (Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel)
2025-02-17
TaqPath™ 1-Step Select Master Mix (No ROX) - Component 4 of 4 of A56123 (Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel)
2025-02-17
TaqPath™ COVID-19, Flu A, Flu B, RSV Select Assay - Component 1 of 4 of A56124 (Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel)
2025-02-17
TaqPath™ COVID-19, Flu A, Flu B, RSV Select Positive Control - Component 2 of 4 of A56124 (Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel)
2025-02-17
TaqPath™ COVID-19, Flu A, Flu B, RSV Select Negative Control - Component 3 of 4 of A56124 (Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel)
2025-02-17
TaqPath™ 1-Step Select Master Mix (No ROX) - Component 4 of 4 of A56124 (Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel)
2025-02-17
Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Assay Kit - Part 1 of 3 of TaqPath™ COVID-19 Diagnostic PCR Kit REF A58505
2025-02-17
Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Control Dilution Buffer - Part 3 of 3 of TaqPath™ COVID-19 Diagnostic PCR Kit REF A58505
2025-02-17
Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Control - Part 2 of 3 of TaqPath™ COVID-19 Diagnostic PCR Kit REF A58505
2025-02-17
Oncomine™ Dx Target DNA Control Kit - ONC DX TARGET DNA CONTROL
2017-06-27
NED-000201 CEL-MIR-40 ASSAY - A51059
2021-03-03
Oncomine™ Dx Target Test - ONC UNIV DX RNA/DNA PANEL IVD
2017-06-27
SpeciMAX Dx Saliva Collection Kit - SPECIMAX SALIVA KIT, IVD
2022-04-13
Earle's Balanced Salt Solution (EBSS) - 14155063
2016-08-04
Histogrip 50x Concentrate - 008050
2018-02-02
Histomount Ready-to-use - 008030
2018-02-02
Hanks' Balanced Salt Solution (HBSS) - 14170120
2016-08-04
SMN2MGB Probe - SMN2MGBPROBE
2019-02-21
Aim -V™ Medium - AIM V MED
2016-08-01
Human CD99 FITC Conjugate - HU CD99 3B2/TA8 FITC MAB
2018-06-15
Human CD99 R-PE Conjugate - HU CD99 3B2/TA8 PE MAB
2018-06-15
Human CXCR4 (CD184) R-PE Conjugate - HU CXCR4 12G5 PE MAB
2018-06-15
Anti-Human HLA-DR (Class II) FITC Conjugate - HU HLA-DR TU36 FITC MAB
2018-06-15