Run the checker

FDA source snapshot

CLIA-waived test list: an analyte-level research snapshot.

Ask about my application — no payment today

This snapshot contains 156 analyte labels retrieved from the FDA source on 2026-09-19. It is not a catalog of test kits, manufacturers, methods, specimen types, intended uses, or current device status. Pick a label for research context, then verify the exact test system manually against current official evidence.

Source retrieved 2026-09-19 · refresh due 2026-10-20

An analyte label only indicates that the retrieved source contained that label. It never confirms that a particular product or use is waived.

6-ACETYLMORPHINE Adenovirus Aerobic/anaerobic Organisms - Vaginal Alanine Aminotransferase (ALT) (sgpt)Albumin Albumin, Urinary Alcohol, Saliva Alkaline Phosphatase (alp)Amines Amphetamines Amylase Aspartate Aminotransferase (AST) (sgot)B-type Natriuretic Peptide (bnp)Bacteria Associated with Bacterial Vaginosis Barbiturates Benzodiazepines Bilirubin, Total Bladder Tumor Associated Antigen Bordetella Species Buprenorphine Calcium, Ionized Calcium, Total Cannabinoids (THC)Carbon Dioxide, Total (CO2)Catalase, Urine Chlamydia Chloride Cholesterol Cocaine Metabolites Collagen Type I Crosslink, N-telopeptides (NTX)Cotinine Creatine Kinase (ck)Creatinine Eddp (methadone Metabolite)Erythrocyte Sedimentation Rate, Nonautomated, Waived ESTRONE-3 Glucuronide Ethanol (alcohol)Fecal Occult Blood Fentanyl Fern Test, Saliva Follicle Stimulating Hormone (FSH)Fructosamine Gamma Glutamyl Transferase (GGT)Gastric Occult Blood Gastric PH Glucose Glucose Monitoring Devices (fda Cleared/home Use)Glucose Monitoring Devices (prescription Use Only)Glucose, Fluid (approved by Fda for Prescription Home Use)Glycated Hemoglobin, Total Glycosylated Hemoglobin (hgb A1C)HCG, Urine Hcv RNA HDL Cholesterol Helicobacter Pylori Helicobacter Pylori Antibodies Hematocrit Hemoglobin Hemoglobin by Copper Sulfate, Nonautomated Hepatitis C Virus Antibody Herpes Simplex I And/or Ii Antibodies Hgb, Single Analyte Inst. W/self-cont.HIV Antibodies HIV-1 and HIV-2 Antibodies HIV-1 and HIV-2 Antigens and Antibodies HIV-1 Antibody Host Biomarker Proteins in Blood Host Biomarker Proteins in Blood (virology)Immunoglobulins Ige Infectious Mononucleosis Antibodies (mono)Influenza a Influenza A/b Influenza B Ketone, Blood Ketone, Urine Lactic Acid (lactate)LDL Cholesterol Lead, Blood Leukocyte Esterase, Urinary Lithium Luteinizing Hormone (LH)Lyme Disease Antibodies (borrelia Burgdorferi Abs)Matrix METALLOPROTEINASES-9 (MMP-9)Mean Corpuscular Volume (mcv)Methadone Methadone Metabolite (eddp)Methamphetamine/amphetamine Methamphetamines Methylenedioxymethamphetamine (MDMA)Microalbumin Morphine Mycoplasma Genitalium Neisseria Gonorrhoeae Neutrophil Percentage (neut%)Nicotine And/or Metabolites Nitrite, Urine Norfentanyl Nortriptyline Opiates Osmolality, Tears Ovulation Test (LH) by Visual Color Comparison Oxazepam Oxycodone PH PH, Urine Phencyclidine (PCP)Phenobarbital Phosphorus Platelet Aggregation Platelet Count Potassium Pregnanediol Glucuronide Propoxyphene Protein, Total Prothrombin Time (PT)Red Blood Cell Count (erythrocyte Count) (rbc)Respiratory Bacterial Pathogens Respiratory Syncytial Virus Respiratory Viruses SARS-COV-2 SARS-COV-2 and Other Respiratory Viruses Secobarbital Semen Sodium Spun Microhematocrit Streptococcus, Group a Thyroid Stimulating Hormone (TSH)Tramadol Treponema Pallidum (syphilis) Antibodies Trichomonas Tricyclic Antidepressants Triglyceride Urea (BUN)Uric Acid Urinary Protein, Qualitative Urine Dipstick or Tablet Analytes, Nonautomated Urine HCG by Visual Color Comparison Tests Urine Qualitative Dipstick Ascorbic Acid Urine Qualitative Dipstick Bilirubin Urine Qualitative Dipstick Blood Urine Qualitative Dipstick Chemistries Urine Qualitative Dipstick Creatinine Urine Qualitative Dipstick Glucose Urine Qualitative Dipstick Ketone Urine Qualitative Dipstick Leukocytes Urine Qualitative Dipstick Nitrite Urine Qualitative Dipstick PH Urine Qualitative Dipstick Protein Urine Qualitative Dipstick Specific Gravity Urine Qualitative Dipstick Urobilinogen Vaginal PH Viral Biothreat Agents Panel White Blood Cell Count (leukocyte Count) (WBC)White Blood Cell Differential (WBC Diff)Whole Blood Qualitative Dipstick Glucose Yeast, Candida Only

Need help with your CLIA route?

Tell us where your clinic operates and what you need to prepare or change. You can ask before you know your exact test system. We review the next facts needed before proposing any paid scope.

Request a scope inquiry — no payment today

Business inquiries only. Do not send patient information, test results, dates of birth, government identifiers, credential numbers, or documents.

Clinic state or jurisdictionWhat do you need?Your nameBusiness emailClinic or laboratory nameWhat are you trying to test or change? (optional)I understand that this inquiry is not a filing, professional engagement, payment authorization, or permission to submit anything.

From test research to your application

An analyte label does not confirm a device. The exact test system and the clinic’s state route need separate review before a filing scope or price can be confirmed.