| ABAdvin Biotech INC | San Diego, CA | Enzyme Immunoassay, Amphetamine · Enzyme Immunoassay, Barbiturate · Enzyme Immunoassay, Benzodiazepine+35 more | federal registry |
| BIBiomerica INC | Irvine, CA | Amplifier And Signal Conditioner, Biopotential · Assay, Erythropoietin · Calibrator, Secondary+24 more | federal registry |
| CBCtk Biotech, INC. | Poway, CA | Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus · Antigen, Cf, Psittacosis (Chlamydia Group) · Antigen(Complexed),Prostate Specific,(Cpsa)+58 more | federal registry |
 Genbody America, LLC | Jurupa Valley, CA | — | federal registry |
 Ihealth Manufacturing INC | Irwindale, CA | Covid-19 Multi-Analyte Antigen Device | federal registry |
 Lumiquick Diagnostics, INC. | Santa Clara, CA | Amplifier And Signal Conditioner, Biopotential · Antigens, All Groups, Streptococcus Spp. · Antigens, Cf (Including Cf Control), Adenovirus 1-33+54 more | federal registry |
 Phase Diagnositics, INC. | Garden Grove, CA | Container, Specimen Mailer And Storage, Sterile · Reagent, Coronavirus Serological · Urine Collection Kit (Excludes Hiv Testing) | federal registry |
| SHSiemens Healthcare Diagnostics INC | Walpole, MA | Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) · Acid, Folic, Radioimmunoassay · Acid, Lactic, Enzymatic Method+92 more | federal registry |
 Maxim Biomedical, INC | Rockville, MD | Immunoassay For Detection Of Amniotic Fluid Protein(S). · Single (Specified) Analyte Controls (Assayed And Unassayed) | federal registry |
| ADAbbott Diagnostics Scarborough INC. - 10 Southgate | Scarborough, ME | Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus · Antisera, All Groups, Streptococcus Spp. · Assay For Detection Of Proteases In Chronic Wounds+20 more | federal registry |
| ADAbbott Diagnostics Scarborough, INC. - Westbrook | Westbrook, ME | Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus · Antisera, All Groups, Streptococcus Spp. · Devices Detecting Influenza A, B, And C Virus Antigens+8 more | federal registry |
 Watmind Usa, INC | Jackson, MS | — | federal registry |
 Access Bio, INC. | Monroe Township, NJ | covid 19 detection kits · Dengue Serological Reagents · Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening+9 more | federal registry |
| NPNutra-Med Packaging Murray Rd | East Hanover, NJ | System, Gastrointestinal Motility (Electrical) | federal registry |
| ODOrtho-clinical Diagnostics, INC | Raritan, NJ | Acid, Folic, Radioimmunoassay · Acid, Lactic, Enzymatic Method · Acid, Uric, Uricase (Colorimetric)+120 more | federal registry |
 Princeton Biomeditech CORP | Monmouth Junction, NJ | Antigens, All Groups, Streptococcus Spp. · Antisera, Fluorescent, All Types, Staphylococcus Spp. · Chromatographic Separation, Cpk Isoenzymes+39 more | federal registry |
 Chembio Diagnostic Systems INC. | Medford, NY | Adalimumab Assay · Antigens, Nontreponemal, All · Assayed Quality Control Material For Clinical Microbiology Assays+20 more | federal registry |
 Siemens Healthcare Diagnostics INC. | Tarrytown, NY | Acid, Folic, Radioimmunoassay · Acid, Lactic, Enzymatic Method · Acid Phosphatase, Naphthyl Phosphate+243 more | federal registry |
 Orasure Technologies INC | Bethlehem, PA | Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus · Device For Home Collection And Transport Of Specimens By Lay Users For Use In A Cleared Non-Viral Sti Molecular Assay · Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens+10 more | federal registry |
| ABAzure Biotech INC | Houston, TX | Reagent, Coronavirus Serological | federal registry |
 Healgen Scientific Limited Liability Company | Houston, TX | Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) · Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method · Analyzer, Chemistry (Photometric, Discrete), For Clinical Use+73 more | federal registry |
 Inbios International INC | Seattle, WA | Dengue Serological Reagents · Dengue Virus Antigen Assay · Elisa, Antibody, West Nile Virus+12 more | federal registry |
