agilent.comPD-L1 IHC 22C3 pharmDx
Agilent Technologies, Inc.
Agilent Technologies, Inc.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1217454 | 1217454 | Agilent Technologies, Inc. | 1 | N | 2026-01-01 | 100 Tigan St Highland Park, PO Box 998 Winooski VT US 05404 |
| 2022180 | 2022180 | Agilent Technologies, Inc. | 1 | N | 2026-01-01 | 6392 VIA REAL CARPINTERIA CA US 93013 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 05700571102305 | Mono Mo A-Hu Progesterone Receptor, Cl PgR 636 - Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636 | +1-805-566-6655 | dako.usregulatory@agilent.com |
| 05700571102305 | Mono Mo A-Hu Progesterone Receptor, Cl PgR 636 - Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636 | +1-800-227-9770 | Global.RA@agilent.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 278820 | 1331316884 | P250004 | MMR IHC Panel pharmDx (Dako Omnis) | QNH | 2025-08-15 |
| 278820 | 1513821395 | P230016 | MAGE-A4 IHC 1F9 pharmDx | SBL | 2024-08-01 |
| 278820 | 1807928927 | P210026 | Ki-67 IHC pharmDx | QQT | 2021-10-12 |
| 278820 | 1897445323 | P150025 | PD-L1 IHC 28-8 pharmDx | 2015-10-09 | |
| 278820 | 1900722000 | P150013 | PD-L1 IHC 22C3 PHARMDX | PLS | 2015-10-02 |
| 278820 | 1770798214 | K170028 | FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis) | MYA | 2017-12-21 |
| 278820 | 1410636932 | K170005 | FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis) | MXZ | 2017-12-21 |
| 278820 | 1527783934 | K130861 | MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, READY-TO-USE (LINK) | MXZ | 2013-12-09 |
| 278820 | 1119620493 | K120663 | MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPI | MYA | 2013-02-12 |
| 278820 | 1059705213 | K042884 | DAKOCYTOMATION ER/PR PHARMDX KIT | MXZ | 2005-02-15 |
| 278820 | 1627488190 | K020023 | DAKO MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, ANTIBODY FOR IMMUNOENZYMATIC STAINING | MXZ | 2002-02-28 |
| 278820 | 1002646485 | ||||
| 278820 | 1067762266 | ||||
| 278820 | 1110972476 | ||||
| 278820 | 1142230799 | ||||
| 278820 | 1146122900 | ||||
| 278820 | 1216560212 | ||||
| 278820 | 1257793252 | ||||
| 278820 | 1304806037 | ||||
| 299633 | 1317775075 | ||||
| 278820 | 1402276810 | ||||
| 278820 | 1472002432 | ||||
| 299633 | 1478199316 | ||||
| 278820 | 1482555657 | ||||
| 278820 | 1486096455 | ||||
| 278820 | 1521957324 | ||||
| 299633 | 1538953595 | ||||
| 278820 | 1579488418 | ||||
| 278820 | 1608547904 | ||||
| 278820 | 1623174605 | ||||
| 278820 | 1639607475 | ||||
| 278820 | 1651613299 | ||||
| 278820 | 1689426650 | ||||
| 299633 | 1719421585 | ||||
| 278820 | 1752069715 | ||||
| 278820 | 1788411395 | ||||
| 278820 | 1806806026 | ||||
| 278820 | 1809175872 | ||||
| 278820 | 1859284327 | ||||
| 278820 | 1931466733 | ||||
| 299633 | 1940855413 | ||||
| 278820 | 1974263604 | ||||
| 278820 | 2005256413 |
Product Codes Associated With Registrations#
PMA#
PD-L1 IHC 22C3 pharmDx
Agilent Technologies, Inc.
PD-L1 IHC 28-8 pharmDx
Agilent Technologies, Inc.
Ki-67 IHC pharmDx
Agilent Technologies, Inc.
PD-L1 IHC 22C3 pharmDx
Agilent Technologies, Inc.
PMN#
GenetiSure Dx Postnatal Assay
Agilent Technologies, Inc.
MODIFICATION TO DEVICE LINK SYSTEM, MODEL M2376A
Agilent Technologies, Inc.
AGILENT M2636B TELEMON B MONITOR (TELEMON B)
AGILENT TECHNOLOGIES, INC.
HEARTSTREAM ATTENUATED DEFIBRILLATION PADS, MODEL M3870A
AGILENT TECHNOLOGIES, INC.
AGILENT INFORMATION CENTER SOFTWARE FOR M3150,M3151,M3153 AND M3154
AGILENT TECHNOLOGIES, INC.
ST/AR ST AND ARRHYTHMIA SOFTWARE, MODEL RELEASE D.0
AGILENT TECHNOLOGIES, INC.
HEARTSTREAM FR2 AED, MODEL M3860A,M3861A
AGILENT TECHNOLOGIES, INC.
M2376A DEVICELINK SYSTEM, MODEL M2376A
AGILENT TECHNOLOGIES, INC.
PAGEWRITER 10/10I, MODEL M2662A HANDHELD ELECTROCARDIOGRAPH
AGILENT TECHNOLOGIES, INC.
M2376A DEVICELINK SYSTEM
AGILENT TECHNOLOGIES, INC.
M2376A DEVICELINK SYSTEM, MODEL M2376A
AGILENT TECHNOLOGIES, INC.
M2424A SONOS 5500/4500 DIAGNOSTIC ULTRASOUND SYSTEM, VERSION B.2. 21330A TRANSDUCER
AGILENT TECHNOLOGIES, INC.
HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL M4735A
AGILENT TECHNOLOGIES, INC.
M2430 DIAGNOSTIC ULTRASOUND SYSTEM WITH THE 21420 TRANSDUCER
AGILENT TECHNOLOGIES, INC.
HP M2376A DEVICE LINK SYSTEM, MODEL M2376A
AGILENT TECHNOLOGIES, INC.
MODIFICATION TO HP M2376A DEVICE LINK SYSTEM, MODEL M2376A
AGILENT TECHNOLOGIES, INC.
COMPACT PORTABLE PATIENT MONITOR WITH WIRELESS ALAN, MODEL ALILENT M3000A/M3046A OPTION J120
AGILENT TECHNOLOGIES, INC.
M2410B IMAGEPOINT HX MULTISPECIALTY SYSTEM, VERSION B.1
AGILENT TECHNOLOGIES, INC.
AGILENT M2636A TELEMON MONITOR
AGILENT TECHNOLOGIES, INC.
ST/AR ST AND ARRHYTHMIA SOFTWARE
AGILENT TECHNOLOGIES, INC.
AGILENT INFORMATION CENTER SOFTWARE FOR M3150A AND M3153A AND AGILENT M2/M3/M4 COMPACT PORTABLE PATIENT MONITOR
AGILENT TECHNOLOGIES, INC.
VIRIDIA INFORMATION CENTER SOFTWARE FOR M3150A AND M3153A, VIRIDIA TELEMETRY SYSTEM TRANSMITTER
AGILENT TECHNOLOGIES, INC.
MODIFICATION TO HP M2376A DEVICE LINK SYSTEM
AGILENT TECHNOLOGIES, INC.
VIRIDIA INFORMATION CENTER SOFTWARE FOR M3154A OPT C22
AGILENT TECHNOLOGIES, INC.
ARI STANDARD ANESTHESIA RECORD
AGILENT TECHNOLOGIES, INC.
GUDID#
PD-L1 Control Slides - T1391
2026-04-29
PD-L1 Control Slides - T1391
2020-11-17
Monoclonal Mouse Anti-Human Integrin Beta-6, Clone 6.2A1 - M3675
2026-01-21
Mono Mo A-Hu Progesterone Receptor, Cl PgR 636 - Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636
2016-09-16
Dako - Dako Omnis Vial with Mixing Ball, 2 mL
2024-08-07
MLH1 IHC pharmDx (Dako Omnis) - GE079
2025-08-27
MSH2 IHC pharmDx (Dako Omnis) - GE085
2025-08-27
MSH6 IHC pharmDx (Dako Omnis) - GE086
2025-08-27
PMS2 IHC pharmDx (Dako Omnis) - GE087
2025-08-27
MMR Negative Control Reagent, Mouse (Dako Omnis) - GE101
2025-08-27
MMR Negative Control Reagent, Rabbit (Dako Omnis) - GE102
2025-08-27
Mono Mo A-Adrenocorticotropin (ACTH) Cl 02A3 - Monoclonal Mouse Anti-Adrenocorticotropin (ACTH) Clone 02A3
2020-09-17
Mono Mo A-Hu Follicle Stimulating Hormone (FSH) Cl C10 - Monoclonal Mouse Anti-Human Follicle Stimulating Hormone (FSH) Clone C10
2020-09-17
Mono Mo A-Hu Beta-Catenin Cl ß-Catenin-1 - Monoclonal Mouse Anti-Human Beta-Catenin Clone ß-Catenin-1
2020-09-17
Mono Mo A-Hu Tyrosinase Cl T311 - Monoclonal Mouse Anti-Human Tyrosinase Clone T311
2020-09-17
Mono Mo A-Thrombomodulin Cl 1009 - Monoclonal Mouse Anti-Thrombomodulin Clone 1009
2020-09-17
Mono Mo A-Hu Luteinizing Hormone (LH) Cl C93 - Monoclonal Mouse Anti-Human Luteinizing Hormone (LH) Clone C93
2020-09-17
Mono Mo A-Hu Muscle Actin Cl HHF35 - Monoclonal Mouse Anti-Human Muscle Actin Clone HHF35
2020-09-17
Mono Mo A-Hu Progesterone Receptor, Cl PgR 1294 - Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294
2016-09-16
Mono Mo A-Hu Thyroid Stimulating Hormone (TSH) Cl 0042 - Monoclonal Mouse Anti-Human Thyroid Stimulating Hormone (TSH) Clone 0042
2020-09-17
Mono Mo A-MyoD1 Cl 5.8A - Monoclonal Mouse Anti-MyoD1 Clone 5.8A
2020-09-17
Mono Mo A-Hu CD1a Cl 010 - Monoclonal Mouse Anti-Human CD1a Clone 010
2020-09-17
Mono Mo A-Hu Mammaglobin Cl 304-1A5 - Monoclonal Mouse Anti-Human Mammaglobin Clone 304-1A5
2020-09-17
Mono Mo A-Hu Prostein Cl 10E3 - Monoclonal Mouse Anti-Human Prostein Clone 10E3
2020-09-17
Mono Mo A-Hu CD5 Cl 4C7 - Monoclonal Mouse Anti-Human CD5 Clone 4C7
2020-09-17
FLEX Mono Mo A-Hu Renal Cell Carcinoma Marker Cl SPM314 RTU (Link) - FLEX Monoclonal Mouse Anti-Human Renal Cell Carcinoma Marker Clone SPM314 Ready-to-Use (Link)
2020-09-17
FLEX Mono Mo A-Hu Gross Cystic Disease Fluid Protein-15 Cl 23A3 RTU (Link) - FLEX Monoclonal Mouse Anti-Human Gross Cystic Disease Fluid Protein-15 Clone 23A3 Ready-to-Use (Link)
2020-09-17
SureFISH 8q24.21 MYC 5' BA 632kb P20 GR - G110458G
2022-06-13
SureFISH 11q13.1 C11orf95 5' 504kb 20 GR - G110476G
2022-06-13
SureFISH 11q13.1 C11orf95 3' 316kb 20 RD - G110477R
2022-06-13
SureFISH 18q21.32 MALT1 DF 672kb P20 RD - G110374R
2022-06-06
SureFISH ALK 3'BA 300kb P20 RD - G110387R
2022-06-06
SureFISH 8q24.21 MYC 3' BA 432kb P20 RD - G110395R
2022-06-06
SureFISH 16p13.1 MYH11 DF 445kb P20 RD - G110421R
2022-06-06
SureFISH 16q22.1 CBFB DF 498kb P20 GR - G110422G
2022-06-06
SureFISH 17p13.3 PAFAH1B1 149kb P20 RD - G110256R
2022-05-30
SureFISH 22q11.21 TUPLE1 101kb P20 RD - G110295R
2022-05-30
SureFISH Xq13.2 XIST 161kb P20 RD - G110296R
2022-05-30
SureFISH 15q12 GABRB3 230kb P20 RD - G110298R
2022-05-30
SureFISH Xp22.31 KAL1 186kb P20 RD - G110299R
2022-05-30