BIOGENEX LABORATORIES INC.

FDA Device Registration & Listing · Fremont, CA, US · Registration 3008776165

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3008776165
FEI Number
2936532
Entity Name
BIOGENEX LABORATORIES INC.
City/State/Country
Fremont, CA, US
Establishment Address
48810 Kato Road,Suite 100E&200E, Fremont, CA 94538, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
BIOGENEX LABORATORIES INC. (Owner Number: 2936532)
Owner / Operator Contact Address
48810 Kato Road,Suite 100E&200E, --, Fremont, CA 94538, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

METHYL GREEN IRON STAINS RETICULUM OPTIPLUS POSITIVE-CHARGED M AFB Green Kit MAYER'S (NON-ALCOHOL BASED) HEMATOXYLIN Periodic Acid-Schiff (PAS) Stain Kit I1000 OIL RED O GROCOTT'S METHENAMINE SILVER BUFFER SOLUTIONS Acid-Fast Bacteria Stain Kit(blue) Giemsa Stain Kit Gram Stain Kit Grocott's Methenamine Silver (GMS) Stain Kit AFB Green Kit MASSON TRICHROME BioGenex Mouse Anti-ER (Clone ER88) BioGenex Mouse Anti-PR (Clone PR88) Toluidine Blue Stain Xmount DILUENT Retrievit 2 Anti-PAP Anti-p53 Protein Anti-CD1a BLOCKING REAGENT II GOAT SERUM Anti-Macrophage Anti-MUC5AC EZ-DeWax Anti-Survivin Link-Label ISH Core Kit II Link-Label ISH Core Kit III Hybridization Buffer Anti-CD29 Clear Mount Anti-Thyroglobulin Anti-CD8 AEC CHROMOGEN Anti-Proliferating cell Super Sensitive IHC Detection System for Automation - Rat Link HRP/DAB Anti-Mucin-1 Anti-lgG New Fuschin Substrate Pack POWER BLOCK (10X) Anti-Alpha-1-Antitrypsin Antigen Retrieval AR-10 Anti-Cytokeratin 5 Anti - P63 + CK5 Anti-Myeloid Sp. Ag Anti-Mesothelin Anti-Aberr.Endoth.Cell Super Sensitive Polymer-HRP IHC Detection System Anti-Heat Shock PEPSIN 3-PACK KIT Anti-Cytokeratin 10 Anti-FSH Anti-Actin H & E RETRIEVAL SOLUTION Anti-CD99 Anti - CDX-2 + Cytokeratin 7 Anti-MMP-9 Anti-P504S/AMACR Mounting Medium Anti-CDX-2 Anti-Alpha-hCG Anti-Cytokeratin 16 Anti-Tenasin Anti-AFP Anti-TTF-1 Anti-HSP 70 ONE STEP AEC SOLUTION Anti-GCDFP-15 Anti-Fascin Anti-HAS Anti-Multy-Drug Resist. Substrate LIQUID DAB ENHANCER ANTIGEN RETRIEVAL CITRA PLUS Anti-Synaptophysin Antigen Retrieval 3 Anti-Osteonectin Anti-CD8(C-term) Anti-Cytokeratin 7 RNase Block EZ-AR 2 ELEGANCE, RTU LEVAMISOLE Anti-CD71 Anti-Melanoma Anti-TFPU.1 Anti-Secretin Anti-Lysozyme PHOSPHATE BUFFER SALINE (PBS) Anti-CD105 Anti-Caldesmon HMW Anti-ZAP-70 AEC SUBSTRATE PACK KIT Anti-Myosin Heavy Chain Anti-CD20 Anti-CD79a Anti-DOG1 XISH Polymer-HRP ISH Detection System Anti-PTEN Super Sensitive One Step Polymer HRP IHC Detection System Anti-Caldesmon Anti-p63 Anti-Calcitonin Anti-CD16 Anti-CD33 Anti-Villin Anti-ACTH Anti-Lambda Light Chain Anti-HSP 27 H & E Kit Anti-Estrogen Receptor Beta Anti-HGH Anti-Sarcomeric Actin Anti-c-jun Protein Anti Cytokeratin 13 Diastase (Alpha-Amylase) Anti-CA19-9 DeCal Retrieval Solution Anti-Bcl-X Anti-CD3 (T cell) Anti-CD4 Anti-Apolipoprotein-E Anti-CD44 Link Diluent Anti-PLAP Anti-PECAM Anti-CD227 Anti-Cytokertin HMW Anti-lgM AQUEOUS MOUNTING MEDIUM Anti-GFAP Fast Red Chromogen Anti-CD9 Anti-CDw75 (B cell) Anti-CD35 Anti-Cytokertin 8 & 18 Anti-Stat5-Alpha(C-term) Anti-ProExc Link-Label ISH Core Kit I HEMATOXYLIN Anti-Cytokeratin 20 Anti-Alpha Actinin Anti-Cytokeratin 6 Anti -CD5 Anti-Fibronectin Anti-CD66 Anti-Transferrin LIQUID DAB SUBSTRATE PACK Anti-Calretinin Anti-Breast Ca. Ag SS Link Anti-Complement C3 Anti-c-myc Protein Anti-lgD Anti-Ki67 Antigen Anti-p21 iso-IHC DAB KIT Anti-CD30 (Ki-1Ag) Anti-CD14 Anti-hGH Anti-Bcl-2 Anti-CD3 epsilon SUPER SENSITIVE POLYMER-HRP ISH DETECTION SYSTEM CONC MULTILINK Anti-Collagen IV Anti-CEA Super Sensitive Label Anti-CD61 Anti-Beta-Catenin Anti-Cyclin D1 Anti-P Carinii Anti-Topo2 Alpha Anti-CD11b Retrievit 4 EZ-AR 3 Anti-CD15 Anti-Estradiol IHC for Rat antibodies on Mouse tissues, Ready-to-Use DAB Kit Anti-Myf4 iso-IHC AEC KIT Anti-Thyroxine Anti-CD11b/ITAM 2-Component DAB Pack Anti-bcl-2-Oncoprotein Anti-CD 31 (Endothelial cell) Anti-CD31 Anti-Kappa Light Chain Anti-Mucin-2 (MUC-2) Fast Red Substrate Pack Anti-CD43 Anti-PDGF-Beta BCIP/NBT Reagent Anti-Insulin Anti-IgM Anti-Ki-67 Anti-CD19 Anti-CD30 Anti CD5 + CD23 Anti-ERG Anti-CD2 SS Multilink Detection Kit, HRP/AEC Anti-Tyrosinase Nuclear Fast Red Anti-LH Anti-Prolactin Super Sensitive Link Label IHC Detection System Anti-Wilm's Tumor TRYPSIN 4-PACK KIT Anti-CD13 Anti-PMS2 Anti-CD3 + CD20 Anti-E-Caclherin ANTI-CD14 Anti-Beta-Hcg Anti-PSAP Anti-CA125 Anti-Myoglobin Anti-Hemoglobin A PROTEASE XXIV 3-PACK KIT MULTILINK X-DEWAX ELEGANCE RED SUBSTRATE PACK Anti-MUC4 Anti-CD68 COMMON AB DILUENT Anti-CD38 Retrievit 8 Anti-Prealbumin Anti-CD45RC (T cell) Anti - TTF-1 + GCDFP-15 EZ-AR1 ELEGANCE, RTU Anti-BRCA1 Protein Anti-Vimentin Super Sensitive Anti-Tdt Anti-BrdU Anti-Chromogranin A NUCLEIC ACID RETRIEVAL I Anti-GLUT-1 DAB Substrate Anti-Myeloperoxidase Super Sensitive One step Polymer-HRP ISH Detection System Anti-Cytoker anti 5 & 6 Anti-Laminin AR Storage Buffer SS MULTILINK Anti-Myosin DAPI Anti-PDGF Anti-CD34 SUPER SENSITIVE MULTILINK Anti-CD45 Protein Block Anti-ER Anti - TTF1 + Cytokeratin 5/6 Anti-Calponin AEC Substrate Anti-Myelin Basic Prot EZ-AR 4 Anti-CD21 Anti-nm23 Anti Cytokeratin HMW Antigen Retrieval 1 Retrievit 10 Power Block Anti-CD117 Anti-CD 23 Anti-Dystrophin 2 Anti-Actin, Muscle Sp. Super Sensitive Wash Buffer Anti-TAG-72 Anti-VEGF Anti-CD56 TRIS BUFFER, CONC PH 7.6 Anti-Substance P SS LABEL TRYPSIN 3-PACK KIT Anti-VIP Anti-Helicobecler Pylori Anti-MITF Super Sensitive IHC Detection System for Automation - Rabbit Link HRP/DAB Anti-c-erbB-3 (Her-3) Anti-Cathepsin D Anti-Factor VIIIA Anti-Tau Anti-Glucagon EZ-AR Common Anti-p34 Anti-Cytokeratin Pan Anti-IgG Anti-Breast Carcinoma Anti-CD23 ISH DETECTION KIT Anti-PDCD4 Anti-HPL Anti-Desmin Anti-N-Cadherin Anti Cytokeratin Cocktail Anti-Cytokeratin Anti-PR S-A HRP DILUENT Anti-TSH Anti-MSH6 Anti-Cytokeratin 14 Anti-Neurofilament SUPER ENHANCER LIQUID DAB CONC SUBSTRATE BUFFER SS Multilink Detection Kit, HRP/DAB Anti-p27(Kip1) SS Label Retrievit 6 XViz Anti-Cytokeratin 17 Anti-NSE Anti-Cytokeratin 8 AEC SUBSTRATE KIT, CONC Anti-Factor-XIII-A Anti - P16 + Ki67 Anti-B Cell Anti-Ep-CAM Anti-CD45RB Anti-NGF Receptor Anti-CD45 Cocktail PEROXIDE BLOCK PEPSIN 4-PACK KIT Anti-Melan-A Anti-Bax Protein Anti-EGFR Anti-GSTi Proteinase K PROTEASE XXIV 4-PACK KIT Anti-Melanoma Assoc.Ag Anti-BLA-36 Anti-Renal Cell Carcinoma ANTI-CD4 LIQUID DAB CHROMOGEN Anti-S-100 Protein Anti-CD3 Anti - Ki67 + Lambda Light Chain Anti-CD74 Anti-MLH1 Anti-Napsin AVIDIN BIOTIN BLOCKING KIT Methyl Green Anti-COX2 Anti-Oct-2 Anti-MCM2 IHC DAB Kit Super Sensitive IHC Detection System for Automation - Mouse Link HRP/DAB Anti-CD5 Anti-Paxillin Anti-p 120 Catenin XViz Detection Kit Anti-p105 PANA Anti-Cyclin E2 Anti-CD138 SUPER MOUNT Anti-ATT Mouse Block Reagent Anti-Collagen III Anti-TGF Alpha Anti-Cytokeratin LMW Anti-CD25 ANTIGEN RETRIEVAL AR-10 (10X) XISH One step Polymer-HRP ISH Detection System for Automation Anti-PSA EZ-AR1 Anti-Catenin delta 1 Anti - CD10 + Cyclin D1 Anti-CD20 (B cell) ANTIGEN RETRIEVAL AR-10 RTU Anti-CD45 (B cell) Anti-Calponin-1 EZ-AR2 Special Stain Wash solution (20X) Anti-FOXP1 Anti-Cytokeratin, Pan Anti-CD11c Anti-lgA Anti-Cytokeratin 19 Anti-Mest Cell Tryptase Anti-Alk/p80 Anti-CD10 Anti-GLEPP-1 Anti-TIA-1 Anti-EMA X-Wash SS Wash Buffer Anti-J Chain Anti-Epithelial Sp. Ag. Anti-Melanoma gp100 Anti-CD45RO (T-Cell) NEGATIVE CONTROL X-Wash Buffer for Xmatrx Antigen Retrieval 2 ANTIGEN RETRIEVAL CITRA Anti-Gastrin Anti-CD57 Anti-Factor XIIIa Anti-Claudin 1 Anti-pS2 Estrogen Biotin Labelling Reagent Anti-p27 Anti-CD43 & CD45RA Anti-Cytokeratin 18 Anti-Inrlioin Alpha Anti-CD22 One-Step Dehydration and Clearing Reagent Anti-PCNA EZ-AR Sampler Kit Anti-Pax5 Anti-CD7 Anti-Human LAG3 Anti-Human BCR-ABL Anti-PD-L1 Anti-Human GITR Anti-Human CDK9 [K.513.1] Anti-Human IDO [4D2] Anti-Human CDK1 [ A17.1.1] Anti-Human CD73 [1D7] Anti-Human CSF-1R [SP211] Anti-Human CD40 [CL1673] Anti-Human SLAMF7 Anti-Human CD27 Ant-PD1 Anti-Human CEACAM1 ANTI-CDW75 (B CELL) ANTI-CYTOKERATIN 15 ANTI-MUCIN 1 (MUC1) GOAT, SS NEG CONTROL ANTI-PLACENTAL LACTOGEN (HPL) ANTI-EPITHELIAL-SPECIFIC ANTIGEN ANTI-C-MYC PROTEIN ANTI-FASCIN ANTI-BASIC FIBROBLAST GROWTH FACTOR (BFGF) EFISH HISTO ANTI-CD11B/ITAM BLOCKING REAGENT II RABBIT SERUM ANTI-CD19 ANTI-CD66 ANTI-MUC4 ANTI-MELANOMA-ASSOCIATED ANTIGEN ANTI-MMP-9 ANTI-CYTOKERATIN 18 ANTI-ABERRANT ENDOTHELIAL CELL ENZYME PWDR PROTEASE XXIV 3-PACK KIT ANTI-CD45 COCKTAIL (LEUKOCYTE ANTIGEN, LCA) ANTI-TRANSFERRIN ANTI-GRANULOCYTE ANTI-VIP ANTI-SECRETIN ANTI-MYELOPEROXIDASE (MPO) ANTI-PS2 ESTROGEN INDUCIBLE PROTEIN H & E RETRIEVAL SOLUTION (10X) ANTI-MITF Anti-Human CDK2 [SP80] ANTI-CD11C ANTI-GLUTATHIONE S-TRANSFERASE PI (GST PI) DAB CHROMOGEN, 2.5ML ANTI-MESOTHELIN ANTI-MELANOMA GP100 ANTI-CD35 ANTI-CD45RC (T CELL) ANTI-CD22 ANTI-CD45RB ANTI-VEGF ANTI-P21/WAF1 ANTI-PAXILLIN ANTI-BETA-TUBULIN IV AX163-50D ANTI-VIMENTIN EFISH CYTO ANTI-IGD ANTI-GLIAL FIBRILLARY ACIDIC PROTEIN (GFAP) ANTI-MITOCHONDRIAL ANTIGEN AX298-50D ANTI-CD29 ANTI-ABCC3 ANTI-OSTEONECTIN ANTI-GLUCAGON PROTEASE KIT - XMATRX DX XISH™ ONE STEP POLYMER-HRP DETECTION SYSTEM FOR XMATRX ANTI-MUM/IRF4 ANTI-PDCD4 ANTI-CYTOKERATIN 5&6 ENZYME POWDER TRYPSIN 4-PACK KIT ANTI-CALDESMON HMW, SMOOTH MUSCLE REAGENT KIT FOR DEMO-XMATRX INFINITY ANTI-MYF4 ANTI-CALRETININ ANTI-P27 (KIP1) ANTI-BCL-2? ANTI-GLUT-1 ANTI-P53 ANTI-C-ERBB-3 (HER-3) ANTI-TUMOR-ASSOCIATED GLYCOPROTEIN (TAG-72) ANTI-CD74 (B CELL) ANTI-ALPHA-1-ANTITRYPSIN ANTI-PTEN ANTI-TRANSFORMING GROWTH FACTOR (TGF) ALPHA ANTI-TTF-1 ANTI-P105 PANA ANTI-CD53 DIASTASE (A-AMYLASE) ANTI-ANAPLASTIC LYMPHOMA KINASE (ALK) ANTI-HLA-DR ANTI-PLACENTAL ALKALINE PHOSPHATASE (PLAP) ANTI-PU.1 ANTI-ACTIN MUSCLE-SPECIFIC ANTI-BCL-X ANTI-BLOOD GROUP ANTIGEN LEWIS A ANTI-CYTOKERATIN 7 & 8 ANTI-B LYMPHOCYTE ANTIGEN 36; BLA ANTI-MYELIN BASIC PROTEIN ENZYME POWDER PEPSIN 4-PACK KIT ANTI-LAMININ ANTI-CARCINOEMBRYONIC ANTIGEN (CEA) SS RAT LINK SUPER SENSITIVE ONE-STEP POLYMER-HRP ISH DETECTION SYSTEM-DEMO ANTI-PAX-5 ANTI-BREAST CANCER ANTIGEN (BCA) 225 ENZYME POWDER PEPSIN 3-PACK KIT ANTI-CYTOKERATIN 10 ANTI-CD34 (ENDOTHELIAL CELL) ANTI-PD-1 ANTI-CD16 ANTI-CALPONIN ANTI-PROLIFERATING CELL NUCLEAR ANTIGEN (PCNA) ANTI-CD10 ANTI-FLI1 ANTI-PROLACTIN CONC MOUSE LINK ANTI-MACROPHAGE ANTI-CATENIN DELTA 1 (P120) ANTI-P120 (CATENIN DELTA 1) ANTI-P34 (CDC2 CYCLIN DEPENDENT KINASE) DEMO KIT-DAB (2 COMPONENT) ANTI-CYTOKERATIN HMW (BASIC) SS GOAT LINK ANTI-CD56 (NATURAL KILLER CELL, NCAM) REAGENT KIT FOR DEMO-XMATRX DIAGNOSTICS ANTI-BAX PROTEIN ANTI-COLLAGEN IV ANTI-COLLAGEN III ANTI-CYTOKERATIN 13 ANTI-TDT ANTI-CD43 & CD45RA COCKTAIL SS MOUSE NEGATIVE CONTROL POWER BLOCK REAGENT, 10X ANTI-CD31 (ENDOTHELIAL CELL) ANTI-CD146 ANTI-THYROGLOBULIN ANTI-CD227 (MUCIN 1) ANTI-CD79A ANTI-OCT-2 ANTI-ACTIN SMOOTH MUSCLE ANTI-FACTOR VIII-RELATED ANTIGEN ANTI-PROSTATE SPECIFIC ACID PHOSPHATASE (PSAP) ANTI-FACTOR XIIIA CONC GOAT LINK ANTI-CYTOKERATIN 7 ANTI-CD38 ANTI-MLH1 RABBIT, SS NEG CONROL ANTI-ALPHA-ACTININ ANTI-MYOSIN HEAVY CHAIN, SMOOTH MUSCLE ANTI-HSA ANTI-CD2 ANTI-BCL-6 ANTI-CYTOKERATIN 8 ANTI-BCL-2 ONCOPROTEIN ANTI-CD45 (LEUKOCYTE COMMON ANTIGEN, LCA) AX001-50D ANTI-MELANOMA ANTI-CA 19-9 ANTI-CD1A ANTI-ACTH ANTI-MYOGENIN ANTI-MSH2 ANTI-RENAL CELL CARCINOMA (RCC) ANTI-ALPHA-1-ANTICHYMOTRYPSIN ANTI-CALPONIN-1 ANTI-CD44 (PHAGOCYTIC GLYCOPROTEIN-1, HCAM) ANTI-CD138 ANTI-S100P ANTI-CD15 (BLOOD GROUP ANTIGEN LEWIS X) ANTI-NEUROFILAMENT ANTI-CYTOKERATIN 8 &18 ANTI-MUCIN 2 (MUC2) ANTI-SUBSTANCE P ENZYME POWDER TRYPSIN 3-PACK KIT ANTI-MAST CELL TRYPTASE ANTI-GLOMERULAR EPITHELIAL PROTEIN 1 (GLEPP-1) ANTI-CD105 ANTI-CD82 ANTI-CD20 ANTI-LYSOZYME ANTI-B CELL ANTI-CYCLIN E1 ANTI-CD117 ANTI-CD13 ANTI-CYTOKERATIN 6 ANTI-CYTOKERATIN, PAN ANTI-MSH6 ANTI-CD45RA (B CELL) ANTI-P63 ANTI-ALK/P80 POLY-HRP ISH DETECTION SYSTEM HER-2 NEU CELL LINE CONTROL SLIDES ANTI-BETA-TUBULIN III ANTI-MELAN-A (MART-1) ANTI-BETA-TUBULIN ANTI-GASTRIN ANTI-CD57 (NATURAL KILLER CELL) ANTI-INHIBIN-ALPHA ANTI-FOLLICLE STIMULATING HORMONE (FSH) ANTI-ERG, ETS-RELATED GENE ANTI-CA 125 ANTI-NAPSIN A ANTI-KRAS ANTI-MULTI-DRUG RESISTANCE MARKER (P-GLYCOPROTEIN) ANTI-CD7 ANTI-S100 BETA ANTI-MYOSIN, SKELETAL MUSCLE ANTI-EP-CAM ANTI-CYTOKERATIN 19 ANTI-CHORIONIC GONADOTROPIN (HCG) BETA CONC STREPT LABEL AP ANTI-TYROSINASE ANTI-ALPHA-FETOPROTEIN (AFP) ANTI-CYTOKERATIN, LOW MW ANTI-HEMOGLOBIN A ANTI-CYTOKERATIN COCKTAIL ANTI-PAP ANTI-CYTOKERATIN COCKTAIL, BROAD SPECTRUM ANTI-ALPHA-TUBULIN ANTI-GCDFP-15 ANTI-KI-67 + LAMBDA LIGHT CHAIN ANTI-CD45RO (T CELL) ANTI-CD117/C-KIT/SCF-RECEPTOR ANTI-HEAT SHOCK PROTEIN 27 (HSP 27) ANTI-GROWTH HORMON (HGH) ANTI-HEAT SHOCK PROTEIN 70 (HSP 70) ANTI-LUTEINIZING HORMONE (LH) ANTI-CYTOKERATIN, HIGH MW ANTI-CATHEPSIN D ANTI-MUC5AC SUPER SENSITIVE ONE STEP POLYMER-HRP ISH DETECTION SYSTEM ANTI-CYTOKERATIN 20 ANTI-CD90 ANTI-CD20 (B CELL) ANTI-NEURON SPECIFIC ENOLASE (NSE) RAT, SS NEG CONTROL NEW FUCHSIN SUBSTRATE PACK ANTI-THYROXINE ANTI-VIMENTIN ANTI-RIBONUCLEOPROTEIN (RNP) ANTI-CD31 (PECAM-1) ENZYME PWDR PROTEASE XXIV 4-PACK KIT ANTI-BETA-CATENIN ANTI-BETA-TUBULIN II ANTI-CYTOKERATIN 17 ANTI-TIA-1 ANTI-TOPOISOMERASE II, ALPHA (TOP2A) ANTI-CD23 ANTI-SARCOMERIC ACTIN ANTI-DOG1 ANTI-ESTRADIOL ANTI-PROSTATE SPECIFIC ANTIGEN (PSA) ANTI-BCL-2 ANTI-MUSCLE ACTINS ANTI-CDK2 ANTI-NGF RECEPTOR ANTI-OCT-4 ANTI-CLAUDIN-5 ANTI-PLATELET-DERIVED GROWTH FACTOR (PDGF) ANTI-COAGULATION FACTOR XIIIA ANTI-CALDESMON ANTI-IGA ANTI-BLOOD GROUP ANTIGEN LEWIS B ANTI-SURVIVIN ANTI-DESMIN CONC RABBIT LINK ANTI-BRCA1 PROTEIN Anti p63 Anti Steroidogenic Factor 1 Anti Cyclin D3 Anti Filaggrin Anti MUC6 Anti PRAME New and Improved Super Sensitive Polymer HRP IHC Detection System Anti CD20 Anti Granzyme B Anti CD64 Anti SFTPD Anti AMACR Anti CD171 NCAM L1 Anti HCGa Anti SATB2 Anti Tubulin Beta3 Anti IgG Anti PAX5 Anti CA IX Anti CD61 Integrin Beta3 Anti Cytokeratin 16 Anti LI cadherin CDH17 Anti Pancreatic Lipase Anti WT1 Anti Interleukin 1beta Anti Perforin 1 Anti Cytokeratin 5 Anti Mammaglobin Anti Pax 5 eFISH Cyto Kit For NanoVIP XISH One step polymer HRP Detection System for NanoVIP Anti CTLA 4 Anti ARID1A Anti Caspase 3 p17 Anti CD23 Anti HIF 1 ALPHA Anti IL 5 Anti Neu Anti Somatostatin Anti Tau Anti Langerin Anti Pygopus 2 Anti Adipophilin Anti Desmoglein 3 Anti GH Anti PD 1 Anti RRM1 Anti CD20 MS4A1 Anti ATRX Anti VISTA Anti BAX Protein Anti Galectin 3 Anti HSA Anti PSAP Anti SOX2 Anti Progesterone Receptor Anti Cytokeratin18 Anti GCDFP 15 Anti Melanoma Marker Anti PAX8 Anti Retinoblastoma New and Improved Xviz Polymer HRP Detection System Anti Beta Catenin p120 Anti ACE2 Anti Beta catenin Anti CD3e Anti GATA 3 Anti Human HIF 2 ALPHA Anti SPARC Anti Factor XIIIa Anti MiTF Anti CD105 Endoglin Anti CD31 Anti Claudin 4 Anti INSM1 Anti Mesothelin Anti Nucleophosmin Anti TLE 1 New and Improved Super Sensitive 1 Step Polymer HRP IHC Detection System for NanoVIP Anti AFP Anti CPA1 Anti Arginase 1 Anti Calcitonin Anti CD22 Anti HHV 8 Anti IL 3 Anti SMAD4 Anti Synaptophysin Anti Villin Anti Serum Amyloid A Anti Alpha 1 Antichymotrypsin Anti CD163 Anti EMA Anti Glycophorin A Anti SALL4 Anti ETV4 Anti Desmoglein 1 Anti MCM7 Anti BAP1 Anti Cathepsin K Anti CD269 Anti Chromogranin A Anti INI 1 Anti NGF Receptor P57 CD271 Anti Thyroid peroxidase Anti Interleukin 6 Anti PD L1 Anti CD95 Anti Cytokeratin 20 Anti Lysozyme Anti PAX3 Anti betaAmyloid New and Improved Super Sensitive Polymer HRP IHC Detection System for Automation Anti Myosin Heavy chain Anti CD133 Anti C myc Anti Kappa Light Chain Anti MLH 1 Anti OCT 3 4 Anti PIT 1 Anti Transthyretin New and Improved Super Sensitive One Step Polymer HRP Detection System DAB Large Volume Anti Fibronectin Anti MYOD1 Anti CD123 Anti Clusterin Anti Interferon Alpha Anti Microglia AIF1 Iba1 Anti NUT1 Anti TMPRSS2 New and Improved Super Sensitive Polymer HRP IHC Detection kit for NanoVIP Anti ALDH1A1 Anti PARP 1 Anti TARDBP Anti CD35 Anti MUM1 Anti PROLACTIN New and Improved Super Sensitive Polymer HRP IHC Detection System Large Volume Anti Alpha 1 Antitrypsin Anti Thymidylate Synthase Anti FSH BETA Anti MYF 4 Anti Prostein Anti SOX10 New and Improved Super Sensitive Polymer HRP IHC Detection System Mega Volume Anti Arginase Anti TIM3 Anti FTL Anti HLA DR DP DQ DX Anti N cadherin Anti PSA Prostate Specific Antigen Anti SOX 11 Anti NESTIN Anti CD137 Anti CNPaseMyelin Anti ERa Anti KI67 Anti MSH2 Anti OLIG2 Anti PLA2R New and Improved Super Sensitive One Step Polymer HRP Detection System DAB for Automation Anti Glutamine Synthetase Anti R1 Anti ALK CD246 Anti EGFR Anti Glucagon Anti PDGFR BETA Anti S100B Anti Cytokeratin 7 Anti PGP9.5 UchL1 Anti Cytokeratin pan Anti MCM3 Anti PAX 7 Anti P Tyr eFISH Histo Kit For NanoVIP New and Improved Xviz Detection Kit for Xmatrx Liquid AEC Solution Anti C4D Anti FOXP1 Anti Actin Muscle Specific Anti BOB 1 Anti CD4 Anti Human PTEN Anti SPEC1 Anti IL6ST Anti PDGFR Beta Anti CD8A Anti CYTOKERATIN 17 Anti EBV LMP 1 Anti PAX2 Anti beta Actin New and Improved Super Sensitive Polymer HRP IHC Detection Kit Mega Volume Anti NKX2.2 Anti SLAMF7 Anti CD147 Anti Cyclin B1 Anti Estrogen Receptor Alpha Anti MSH6 Anti p120 Catenin delta 1 Anti PMS2 New and Improved Super Sensitive One Step Polymer HRP Detection System DAB Mega Volume Anti OPN Anti Smoothelin Anti Cyclin D1 Estrogen Receptor beta 1 Anti MTAP Anti P16 Anti Podoplanin New and Improved Super Sensitive One Step Polymer HRP Detection System DAB for Xmatrx BGX HRP Green Kit Anti Ep CAM Anti MDM2 Anti CD10 Anti CD30 Anti c Jun Anti INI1 SNF5 SMARCB1 Anti Nkx3.2 Anti TIGIT New and Improved Super Sensitive 1 step Polymer HRP Detection System Anti IDH1 Anti C4d Anti CD57 Anti CYTOKERATIN 13 Anti IL 1a Anti LI Cadherin Cadherin 17 Anti p57 kip2 Anti Vwf Anti CD162 Anti GM CSF Anti BrdU Anti CD47 Anti IgG4 Anti Laminin Receptor Anti STAT 3 Anti VEGF Anti Cytokeratin Anti Aurora B Anti Cathepsin D Anti CD235a Glycophorin A Anti CDK4 Anti HLA Class 1 ABC MHC I Anti Inhibin alpha Anti NeuN Anti TFE3 Anti Caspase 3 Anti FSH Receptor Anti Brachyury Anti CD45 LCA Anti IGA Anti SSTR2 Anti TTF 1 Anti CD11b Anti GLUT1 Anti BRCA 1 Anti CD45RA Anti IgD Anti Lamin B1 Anti STAT6 Anti UPIIIa Anti NKX3.1 Anti c Myc Anti Annexin VII Anti CD21 Anti Hemoglobin A Anti IL 2 Anti Serum Amyloid P Anti SV40 T Ag Anti BCOR Anti YAP Anti BCA 225 Anti Gastrin Anti Human FLI 1 Anti PTEN Anti SOX9 Anti HSV Cocktail Anti Brg 1 Anti CD56 Anti IL 15 Anti LEF1 Anti p21 WAF1 Anti STAT5A Anti VIP Anti Histone H3 Anti CEACAM1 Anti Annexin A1 Anti CD2 Anti Helicobacter pylori Anti SDHB Anti STAT 6 BGX HRP Black Kit PAP PAPANICOLAU Reticulin/No Counterstain Stain Gomori's Blue Trichrome Stain Colloidal Iron Gomori's Trichrome Green Stain van Gieson Stain Renal Masson's Trichome Mucicarmine Stain Jones' Basement Membrane Stain Sudan Black B Stain PAS Diastase Congo Red Stain Oil Red O Stain PAS for fungi stain RETICULIN/NUCLEAR FAST RED STAIN KIT ALIZARIN RED STAIN SUDAN BLACK Azure A Stain Alcian Blue pH 2.5 Stain Alcian Blue /PAS stain Xmount OPTIMAX WASH BUFFER (20X) ANTIGEN RETRIEVAL Super Sensitive Wash Buffer XMATRX NANO AUTOMATED STAINING SYSTEM Xmatrx Infinity Xmatrx® Diagnostics i6000 Diagnostics Xmatrx Elite Diagnostics Xmatrx Nano Xmatrx FISH Xmatrx Ultra Diagnostics Xmatrx Ultra Infinity i6000 infinity i6000® ELITE Dx XMATRX® NANO VIP EZ-Retriever ® System MICROWAVE AR SINGLE ACCESS, KIT XMATRX® MINI Xmatrx® ULTRA Rx Xmatrx® ULTRA Dx i6000® ELITE Rx XMATRX AUTOMATED STAINING SYSTEM EZ Retriever System NanoVip NanoMtrx100 NanoVip300 CONGO RED Safranin O Stain

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HZA Methyl Green Hematology Class 1 864.1850 1997-03-26
GGH Iron Stains Hematology Class 1 864.1850 2002-03-26
KKP Solution, Silver Carbonate Hematology Class 1 864.1850 2005-02-03
KEW Slides, Microscope Pathology Class 1 864.3010 2004-07-29
ICL Carbol Fuchsin Hematology Class 1 864.1850 2002-03-26
HYL Hematoxylin Mayer'S Hematology Class 1 864.1850 1997-03-26
HZT Reagent, Schiff Hematology Class 1 864.1850 1999-03-03
IEO Processor, Tissue, Automated Pathology Class 1 864.3875 2002-03-26
HZG Oil Red O Hematology Class 1 864.1850 2002-03-26
HYZ Methenamine Silver Hematology Class 1 864.1850 2002-03-26
JCC Ph Buffer Pathology Class 1 864.4010 2005-02-03
JTS Stains, Microbiologic Hematology Class 1 864.1850 2002-03-26
HYW Stain, Trichrome, Mallory'S Hematology Class 1 864.1850 2002-03-26
MYA Immunohistochemistry Antibody Assay, Estrogen Receptor Hematology Class 2 864.1860 2007-12-10
MXZ Immunohistochemistry Assay, Antibody, Progesterone Receptor Hematology Class 2 864.1860 2007-12-10
IAB Toluidine Blue Hematology Class 1 864.1850 2013-12-04
NJT Immunohistochemistry Reagents And Kits Hematology Class 1 864.1860 2005-02-03
HZJ Stain, Papanicolau Hematology Class 1 864.1850 2002-03-26
LEE Stains, Dye Solution Hematology Class 1 864.1850 2005-02-03
HZZ Sudan Black B Hematology Class 1 864.1850 2002-03-26
ICQ Azure A Hematology Class 1 864.1850 2013-12-04
IDA Alcian Blue Hematology Class 1 864.1850 2002-03-26
PPM General Purpose Reagent Pathology Class 1 864.4010 1997-03-26
KEY Stainer, Tissue, Automated Pathology Class 1 864.3800 1994-09-23
ICH Congo Red Hematology Class 1 864.1850 2002-03-26
HZS Safranin Hematology Class 1 864.1850 2013-12-04

Official Correspondent

KRISHAN KALRA

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BIOGENEX LABORATORIES INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
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Other Registrations for Same Entity

Registration Number Establishment Name Location
3007648367 BioGenex Life Sciences Pvt. Ltd. Ranga Reddy District Telangana, IN

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K843684 Sigma Chemical Co. SIGMA SUDAN BLACK REAGENT 380-1 1984-10-31

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0025-05 Becton Dickinson & Co. 1
Difco (TM) BBL (TM) Gram Crystal Violet, 250 mL bottles in packs of four, catalog # 212525 and 3.8 L bottles, catalog # 212526, staining reagent.
Z-0014-05 Zymed Laboratories Inc. 2
Mouse anti-TTF-1 concentrate used in a panel designed to differentiate between different types of cancer when used to test a patient.
Z-0015-05 Zymed Laboratories Inc. 2
Mouse anti-TTF-1 2nd Gen Predilute used in a panel designed to differentiate between different types of cancer when used to test a patient.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008776165. Last updated year: 2026. Please use registration number 3008776165 when referencing this establishment in official correspondence.
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