{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-10-19", "results": { "skip": 0, "limit": 1, "total": 3 } }, "results": [ { "proprietary_name": [ "Pax-5 Rabbit Polyclonal Antibody", "Negative Control Mouse", "Keratin 18 (CloneE431-1) Rabbit Monoclonal Antibody", "Neurofilament (200kDa & 68kDa) Ab-1 (Clone 2F11)", "Large Volume Phosphate Buffered Saline (25X)", "Large Volume Phosphate Buffered Saline and Tween 20 (20X)", "GLUT-1 Rabbit Polyclonal Antibody", "CD68 (Macrophage Marker) Ab-3 (Clone KP1)", "Epredia TAG-72 / CA 72-4 (Clone B72.3)", "CA125 (Ovarian Cancer Antigen) Ab-1 (Clone Ov185:1)", "Citrate Buffer For Heat-Induced Epitope Retrieval", "GCDFP-15 Gross Cystic Disease Fluid Protein-15 Ab-1 ( 23A3)", "UltraVision Quanto Detection System HRP DAB", "S100 Protein Ab-1 (Clone 4C4.9) Mouse Monoclonal Antibody", "Large Volume Tris Buffered Saline and Tween 20 (20X)", "CD5 Ab-1 (Clone 4C7) Mouse Monoclonal Antibody", "CD44 Std. / HCAM Ab-4 (Clone 156-3C11)", "EMA Ab-3 (Clone E29)", "GFAP (Glial Fibrillary Acidic Protein) Ab-6 [Clone ASTRO6]", "Keratin 20 Ab-1 (Clone Ks20.8) Mouse Monoclonal Antibody", "c-erbB-2 / HER-2 / neu Ab-17 (Clone e2-4001 + 3B5)", "Factor XIIIA Ab-1 [Clone AC-1A1]", "CD20 Ab-1 (Clone L26) Mouse Monoclonal Antibody", "Keratin 7 Ab-2 [Clone OV-TL 12/30]", "CD4 Ab-8 (Clone 4B12) Mouse Monoclonal Antibody", "UltraVision™ Protein Block", "Factor VIII Related Antigen / von Willebrand Factor Ab-1", "PMS2 (Clone EPR3947) Rabbit Monoclonal Antibody", "Vimentin Ab-2 (Clone V9) Mouse Monoclonal Antibody", "Keratin, Low Molecular Weight Ab-1 (Clone AE1)", "MART-1/Melan-A (Melanoma Marker) Ab-4 [Clone A103]", "Actin, Smooth Muscle Ab-1 (Clone 1A4; same as asm-1)", "CD45RO (T-Cell Marker) Ab-1 (Clone UCHL-1)", "TTF-1 (Thyroid Transcription Factor-1) Ab-1 (Clone 8G7G3/1)", "p504S/ AMACR (Clone 13H4) Rabbit Monoclonal Antibody", "Tartrate Resistant Acid Phosphatase (TRAP)Ab-1 (Clone 26E5)", "CD30 (Reed-Sternberg Cell Marker) Ab-1 (Clone Ber-H2)", "CD68 (Macrophage Marker) Ab-4 (Clone PG-M1)", "Melanoma (gp100) Ab-1 (Clone HMB45)", "Perforin Ab-2 (Clone 5B10) Mouse Monoclonal Antibody", "NY-BR-1 Mouse Monoclonal Antibody", "CD31 / PECAM-1 (Endothelial Cell Marker) Ab-1 ( JC/70A)", "FITC Protein Blocking Agent (PBA)", "Myeloperoxidase (MPO) Ab-1 Rabbit Polyclonal Antibody", "CD15 Ab-3 (Clone MMA; Same as LeuM1)", "Epredia MLH1 (Clone 4C9C7) Mouse Monoclonal Antibody", "Keratin 8 / 18 Ab-1 (Clone 5D3)Mouse Monoclonal Antibody", "ALK / p80 Ab-1 (Clone 5A4) Mouse Monoclonal Antibody", "Keratin, Pan Ab-1 (Clone AE1/AE3) Mouse Monoclonal Antibody", "c-erbB-2 / HER-2 / neu (Clone EP1045Y) Antibody", "Chromogranin A Ab-1 (LK2H10) Mouse Monoclonal Antibody", "Epithelial Specific Antigen / Ep-CAM Ab-1 (Clone VU-1D9)", "CDX2 (Clone EPR2764Y) Rabbit Monoclonal Antibody", "Estrogen Receptor Ab-11 (Clone 1D5)", "CD1a Ab-5 (Clone O10) Mouse Monoclonal Antibody", "E-Cadherin (Clone EP700Y) Rabbit Monoclonal Antibody", "Epithelial Specific Antigen Ab-9 (Clone Ber-EP4)", "BCL6 (Clone LN22) Mouse Monoclonal Antibody", "Troponin T, Cardiac Isoform Ab-1 (Clone 13-11)", "Large Volume Tris Buffered Saline (25X)", "TdT", "Placental Alk. Phosphatase (PLAP) Ab-4 (Clone 8A9)", "Epredia ERG (Clone 9FY) Mouse Monoclonal Antibody", "CD2 (LFA-2) Ab-2 (Clone AB75) Mouse Monoclonal Antibody", "Mesothelioma Ab-1 (Clone HBME-1) Mouse Monoclonal Antibody", "UltraVision™ Quanto Detection System HRP DAB", "CD56 / NCAM-1 Ab-4 [56C04; same as 123A8]", "Keratin 5 Ab-1 (Clone XM26) Mouse Monoclonal Antibody", "DAB Quanto", "bcl-2?Ab-1 (Clone 100/D5) Mouse Monoclonal Antibody", "Keratin 19 Ab-1 (Clone A53-B / A2.26, same as Ks19.1)", "p57Kip2 Ab-6 [Clone 57P06; same as KP10]", "Keratin, HMW Ab-3 (Clone 34?E12) Mouse Monoclonal Antibody", "Antibody Diluent OP Quanto", "Lambda Light Chain Ab-2 Rabbit Polyclonal Antibody", "CD138 Ab-2 (Clone MI15) Mouse Monoclonal Antibody", "Kappa Light Chain Ab-2 Rabbit Polyclonal Antibody", "Hepatitis B Virus Surface Antigen Ab-1 ( T9; same as 3E7)", "Villin Ab-1 (Clone CWWB1) Mouse Monoclonal Antibody", "CD21 Ab-2 (Clone 2G9) Mouse Monoclonal Antibody", "Keratin 18 Ab-1 (Clone DC10) Mouse Monoclonal Antibody", "p53 Ab-5 (Clone DO-7) Mouse Monoclonal Antibody", "CD3? (Clone EP449E) Rabbit Monoclonal Antibody", "Mucin 5AC (MUC5AC) / Gastric Mucin Ab-1 (Clone 45M1)", "CD8 Ab-1 (Clone C8/144B) Mouse Monoclonal Antibody", "Human Papilloma Virus (HPV) Ab-3 (Clone K1H8)", "Beta-catenin (Clone E247) Rabbit Monoclonal Antibody", "Keratin 5 (Clone EP1601Y) Rabbit Monoclonal Antibody", "CD117 / c-kit Oncoprotein / SCF-Receptor Antibody", "CD45RA Ab-3 (Clone 4KB5) Mouse Monoclonal Antibody", "Calponin Ab-1 (Clone CALP) Mouse Monoclonal Antibody", "Granzyme B Ab-1 (Clone GZB01) Mouse Monoclonal Antibody", "Mesothelin Ab-1 (Clone 5B2) Mouse Monoclonal Antibody", "Tyrosinase AB-1 [Clone T311]", "Desmin (Muscle Cell Marker) Ab-1 (Clone D33)", "UltraVision™ Hydrogen Peroxide Block", "CD45 / T200 / LCA Ab-2 (Clone PD7/26/16+2B11)", "UltraVision™ Quanto Detection System HRP", "CD23 Ab-1 (Clone 1B12) Mouse Monoclonal Antibody", "CD10/CALLA (Neutral Endopeptidase) Ab-2 (Clone 56C6)", "Glycophorin A Ab-4 (Clone JC159) Mouse Monoclonal Antibody", "Epredia CD34 (Clone QBEnd/10) Mouse Monoclonal Antibody", "Hepatocyte Ab-1 (Clone OCH1E5) Mouse Monoclonal Antibody", "PermaFluor™ Aqueous Mounting Medium", "UltraVision™ Quanto Detection System AP", "Dog1 (Clone 1.1) Mouse Monoclonal Antibody", "Napsin A (Clone EPR6252) Rabbit Monoclonal Antibody", "Keratin 5 / 6 Ab-2 (Clone D5/16 B4)" ], "establishment_type": [ "Manufacture Medical Device for Another Party (Contract Manufacturer)" ], "registration": { "registration_number": "3012214605", "fei_number": "3012214605", "status_code": "1", "initial_importer_flag": "N", "reg_expiry_date_year": "2027", "name": "PROTEINTECH GROUP INC", "address_line_1": "5500 Pearl St", "address_line_2": "Suite 400", "city": "Rosemont", "state_code": "IL", "iso_country_code": "US", "zip_code": "60018", "postal_code": "", "us_agent": {}, "owner_operator": { "firm_name": "Proteintech Group Inc", "owner_operator_number": "10083744", "official_correspondent": { "first_name": "Abdul", "middle_initial": "", "last_name": "Issa", "subaccount_company_name": "", "phone_number": "1-312-4558498-823" }, "contact_address": { "address_1": "5500 Pearl St Suite 400", "address_2": "", "city": "Rosemont", "state_code": "IL", "state_province": "", "iso_country_code": "US", "postal_code": "60018" } } }, "pma_number": "", "k_number": "", "products": [ { "product_code": "NJT", "created_date": "2023-07-18", "owner_operator_number": "10083744", "exempt": "", "openfda": { "device_name": "Immunohistochemistry Reagents And Kits", "medical_specialty_description": "Hematology", "regulation_number": "864.1860", "device_class": "1" } } ] } ] }