BEUDAMED
    FDA Registration Active 🇺🇸 United States

    STS CORPORATION

    Reg #: 3014150341 · FEI: 3014150341 · Expires 2026
    View on FDA
    Products
    98
    Proprietary Names
    90
    Establishment Types
    3
    Classifications
    98

    Registration Details

    Registration Name
    STS CORPORATION
    Registration Number
    3014150341
    FEI Number
    3014150341
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    3500 Duluth Park LN, Suite 420
    City
    Duluth
    State
    GA
    ZIP
    30096
    Country
    US

    Owner / Operator

    Firm Name
    STS Corporation
    Operator Number
    10056102
    Address
    3500 Duluth Park LN, Suite 420
    City
    Duluth
    State
    GA
    Postal Code
    30096
    Country
    US
    Correspondent
    Rick Yi

    Products

    Device Name Product Code
    Calibrator For Hemoglobin And Hematocrit Measurement KRZ
    Antigens, All, Leptospira Spp. GRY
    Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) JIR
    Plasma, Coagulation Control GGN
    Antigens, Cf (Including Cf Control), Influenza Virus A, B, C GNX
    Calibrator For Platelet Counting KRY
    Purifier, Water (Absorption, Deionization, Membrane Filter, Reverse Osmosis) JRS
    Splint, Extremity, Non-Inflatable, External, Non-Sterile NOC
    General Purpose Reagent PPM
    Foot Wrap For Treating Restless Leg Syndrome Symptoms OTX
    Antigens, Cf, All, Mycoplasma Spp. GSB
    Syringe, Cartridge EJI
    Fluorometer, For Clinical Use KHO
    Prothrombin-Proconvertin And Thrombotest JPF
    Test, Morphine, Employment And Insurance Testing, Exempt PVG
    Bandage, Cast ITG
    Needle, Aspiration And Injection, Disposable GAA
    Plasma, Control, Normal GIZ
    Plasma, Fibrinogen Control GIL
    Control, Red-Cell GJR
    Quality Control Material, Genetics, Dna NZB
    Control Material, Blood Circulating Epithelial Cancer Cell NRS
    Antiserum, Typhus Fever GPN
    Disinfectant, Subsystem, Water Purification NIH
    Processor, Radiographic-Film, Automatic, Dental EGY
    Calibrator For Cell Indices KRX
    Legging, Compression, Non-Inflatable LLK
    Container, Specimen Mailer And Storage, Temperature Controlled, Sterile KDW
    Test, Benzodiazepine, Employment And Insurance Testing, Exempt PUZ
    Standards And Controls, Hemoglobin, Normal And Abnormal GFS
    Culture Media, Non-Propagating Transport JSM
    Purifier, Water, Ultraviolet, Medical KMG
    Accessory, Surgical Apparel LYU
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    Control, White-Cell GGL
    Hematocrit, Tube, Rack, Sealer, Holder GHY
    Enzyme Linked Immunoabsorbent Assay, Rotavirus LIQ
    Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) DWL
    Antigens, Cf (Including Cf Control), Adenovirus 1-33 GOD
    Transport Medium, Notified Per The Vtm Guidance QMC
    Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis PER
    Control, Hemoglobin GGM
    Kit, Serological, Positive Control MJX
    Multi-Analyte Controls, All Kinds (Assayed) JJY
    Calibrator For Red-Cell And White-Cell Counting KSA
    Syringe, Restorative And Impression Material EID
    Antigens, All Groups, Streptococcus Spp. GTY
    Centrifuge, Hematocrit GKG
    Albumin, Antigen, Antiserum, Control DCF
    Fluid, Diluting, White-Cell GGJ
    Dna Genetic Analyzer PCA
    Applicator, Absorbent Tipped, Sterile KXG
    Biopsy Needle Guide Kit OIJ
    Programmer, Changer, Film/Cassette, Radiographic IZP
    Stocking, Medical Support (For General Medical Purposes) FQL
    Test, Barbiturate, Employment And Insurance Testing, Exempt PUY
    Hemocytometer GHO
    Chromatography (Liquid, Gel), Clinical Use KZR
    Apparatus, Automated Blood Cell Diluting GKH
    Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt PVA
    Syringe, Periodontic, Endodontic, Irrigating EIC
    Norovirus Serological Reagent OUC
    Control, Plasma, Abnormal GGC
    Dressing, Compression MHW
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    High Throughput Dna Sequence Analyzer PFF
    Container, Specimen Mailer And Storage, Temperature Controlled, Non-Sterile NNL
    Processor, Radiographic-Film, Automatic IXW
    Device, Bleeding Time JCA
    Respirator, Surgical MSH
    Control, Fecal Occult Blood OSL
    Reagent, Rickettsia Serological LSQ
    Mixture, Hematology Quality Control JPK
    Syringe, Irrigating (Dental) EIB
    Container, Specimen, Sterile FMH
    Control, Cell Counter, Normal And Abnormal JCN
    Processor, Cine Film IXX
    Component, Cast LGF
    Applicator, Absorbent Tipped, Non-Sterile KXF
    Test, Amphetamine, Employment And Insurance Testing, Exempt PUX
    Antigens, All Groups, Salmonella Spp. GRL
    Test, Methamphetamine, Employment And Insurance Testing, Exempt PVD
    Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus GQG
    System, X-Ray, Film Marking, Radiographic JAC
    Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature FMK
    Control, Hemoglobin, Abnormal JCM
    Control, Hematocrit GLK
    Mixture, Control, White-Cell And Red-Cell Indices GLQ
    Test, Methadone, Employment And Insurance Testing, Exempt PVE
    Device, Beam Limiting, X-Ray, Diagnostic KPW
    Centrifuge, Blood-Bank For In Vitro Diagnostic Use KSO
    Container, Specimen Mailer And Storage, Sterile KDT
    Hemoglobin, Chain Specific, Antigen, Antiserum, Control DAM
    Automated Urinalysis System KQO
    Control, Platelet GJP
    Syringe, Ent KCP
    Kit, Direct Antigen, Positive Control MJZ
    System, Isokinetic Testing And Evaluation IKK

    Proprietary Names

    STSC, General, Calibrator for Hemoglobin and Hematocrit Measurement BioDigit, Leptospira IgG/IgM, Antigens, All, Leptospira Spp. BioDigit, Indicator Method, Urinary Protein or albumin (Non-Quantitative) Test System STSC, General, Plasma, Coagulation Control Asan Pharm Manufactured, GNX 1, BioDigit, Influenza A/B, Antigens, Cf (Including Cf Control), Influenza Virus A, B, C STSC, General, Calibrator for Platelet Counting Water Purifier STSC, GAP, Water Purifier BioMed Lab, Tech, G&W, NEO Splint Exo-I, PPM-1, Passive Exosome Isolation (SEC Columns and Buffers), EXoPERT Enerskin E75 Compression Wrap, Foot Wrap for Treating Restless Leg Syndrome Symptoms BioDigit, Mycoplasma Ag., Antigens, Cf, All, Mycoplasma Spp. (Mycoplasma Spp. Serological Reagents) Syringe, Cartridge, Dental - AMTC-K - EJI 2 STSC, Fluorometer STSC, General, Prothrombin-Proconvertin and Thrombotest BioDigit, Morphine Test System, Test, Morphine, Employment and Insurance Testing BioMed Lab Tech, NEO Cast Needle, Aspiration and Injection, Disposable - AMTC & GAP, GAA, 1 STSC, General, Plasma, Control, Normal STSC, General, Plasma, Fibrinogen Control STSC, General, Control, Red-Cell Qbiosens Qcsl Cell Separation and Lysis Device STSC, General, Control Material Blood Circulating Epithelial Cancer Cell BioDigit, Anti-Tsutsugamushi, Antiserum, Typhus Fever (Rickettsia Serological Reagents) STSC, GAP, Disinfectant, Subsystem, Water Purification System STSC, GAP, Processor, Radiographic-Film, Automatic STSC, General, Calibrator for Cell Indices Enerskin E75 Compression Sleeve, Legging, Compression, Non-Inflatable Asan Pharm Manufactured, BioDigit, KDW 1, Container, Specimen Mailer and Storage, Temperature Controlled, Sterile BioDigit, Benzodiazepine Test System, Test, Benzodiazepine, Employment And Insurance Testing STSC, General, Standards and Controls, Hemoglobin, Normal and Abnormal Asan Viral Transport Media, Non-Progating Transport, JSM Culture Media, Non-Propagating Transport - Asan Viral Transport Media, Asan Pharmaceutical, BioDigit, JSM, 1 STSC, GAP, Purifier, Water, Ultraviolet, Medical AMTC-K & JW KF-94, MFKMT, LYU 1, Accessory, Surgical Apparel, Face Mask ARM Dx, JJE-1, Raman Spectroscopy Analyzer for Exosome Signal Measurement, EXoPERT STSC, General, Hematocrit, Tube, Rack, Sealer, Holder BioDigit, Rotavirus, Enzyme Linked Immunoabsorbent Assay, Rotavirus Enerskin E75 Compression Sleeve, Stocking, Medical Support (To Prevent Pooling of Blood in Legs) BioDigit, Adenovirus, Antigens, Cf (Including Cf Control), Adenovirus 1-33 Asan Viral Transport Media, Notified Per the VTM Guidance, QCM Transport Medium, Notified Per the VTM Guidance - Asan Viral Transport Media, Asan Pharmaceutical, BioDigit, QMC, 1 STSC, General, Automated Pipetting, Diluting and Specimen Processing Workstations for Flow Cytometric Analysis STSC, General, Control Hemoglobin BioDigit, Anti-HBs, Kit, Serological, Positive Control BioDigit, HAV IgG/IgM, Multi-Analyte Controls, All Kinds (Assayed) Syringe, Restorative Impression Material - AMTC-K - EID 1, Dental Hand Instrument BioDigit, Strep A, Antigens, All Groups, Streptococcus Spp. BioDigit, Albumin, Antigen, Antiserum, Control - Albumin Immunological Test System Asan Pharmaceutical Manufactured, BioDigit, KXG 1, Applicator, Absorbent Tipped, Sterile Biopsy Needle Guide Kit - AMTC & GAP, OIJ, 2 STSC, GAP, Programmer, Changer, Film/Cassette, Radiographic Enerskin E75 Compression Stocking, Medical Support (For General Medical Purposes) BioDigit, Barbiturate Test System, Test, Barbiturate, Employment And Insurance Testing ExoTractor, KZR-1, Automated Exosome Isolation Instrument (Uses Exo-i), EXoPERT BioDigit, Cocaine and Cocaine Metabolite Test System, Test, Cocaine And Cocaine Metabolite, Employment & Insurance Test Syringe, Periodontic, Endodontic, Irrigating - AMTC-K - EIC 1, Dental Hand Instrument Qbiosens Qpre Foodborne Virus Detection Device STSC, General, Control, Plasma, Abnormal Enerskin E75® Compression Apparel BioDigit, Anti-Syphilis, Single (Specified) Analyte Controls (Assayed And Unassayed) Asan Pharmaceutical Manufactured, BioDigit, NNL 1, Container, Specimen Mailer and Transport/Storage, Temperature Control Device, Bleeding Time, Hematology - AMTC & GAP, JCA, 2 Jungwoo KF-99, MFKMT, MSH 2, Respirator, Surgical, Face Mask BioDigit, FOB (Fecal Occult Blood) Test, Occult Blood Test BioDigit, Typhoid IgG/IgM, Reagent, Rickettsia Serological STSC, General, Mixture, Hematology Quality Control Syringe, Irrigating, Dental - AMTC-K - EIB 1, Dental Hand Instrument Asan Pharmaceutical Manufactured, BioDigit, FMH 1, Container, Specimen, Sterile STSC, GAP, Processor, Cine Film BioMed Lab Tech, G&W, NEO Cast Asan Pharmaceutical Manufactured, BioDigit, KXF 1, Applicator, Absorbent Tipped, Non-Sterile BioDigit, Amphetamine Test System, Test, Amphetamine, Employment And Insurance Testing BioDigit, Typhoid / Salmonella Spp., Antigens, All Groups, Salmonella Spp. BioDigit, Methamphetamine Test System, Test, Methamphetamine, Employment and Insurance Testing BioDigit, RSV, Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus System, X-Ray, Film Marking, Radiographic - AMTC-K, JAC 1, General Medical Lancet, Blood, Manual Surgical Instrument for General Use - AMTC & GAP, FMK, 1 STSC, General, Control, Hemoglobin, Abnormal STSC, General, Control Hematocrit BioDigit, Methadone Test System, Test, Methadone, Employment and Insurance Testing Device, Beam Limiting, X-Ray, Diagnostic - AMTC-K, KPW 2, General Medical STSC, General, Centrifuge, Blood-Bank for In Vitro Diagnostic Use Asan Pharmaceutical Manufactured, BioDigit, KDT 1, Container, Specimen Mailer and Storage, Sterile Specimen Transport STSC, General, Hemoglobin, Chain Specific, Antigen, Antiserum, Control BioDigit, Blood in Urine (Hematuria), Automated Urinalysis System STSC, General, Control, Platelet Syringe, ENT (Ear, Nose, and Throat) - AMTC-K - KCP 1 BioDigit, Anti-Malaria P.f/P.v, Kit, Direct Antigen, Positive Control Enerskin E75 Compression Apparel, System, Isokinetic Testing and Evaluation System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility