Currently Waived Analytes |
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The following is a list of analytes that are used in laboratory test systems that have been "waived". Under the current process, waiver may be granted to: 1) any test listed in the regulation, 2) any test system for which the manufacturer or producer applies for waiver if that test meets the statutory criteria and the manufacturer provides scientifically valid data verifying that the waiver criteria have been met, and 3) test systems cleared by the FDA for home use. The waived analytes below are linked to waived test systems. Simply click on an analyte of interest to link to test systems that are waived for the analyte.
| Analyte Name |
| ALANINE AMINOTRANSFERASE (ALT) (SGPT) |
| ALBUMIN, URINARY |
| ALCOHOL, SALIVA |
| AMINES |
| AMPHETAMINES |
| ASPARTATE AMINOTRANSFERASE (AST) (SGOT) |
| BLADDER TUMOR ASSOCIATED ANTIGEN |
| CANNABINOIDS (THC) |
| CATALASE, URINE |
| CHOLESTEROL |
| COCAINE METABOLITES |
| COLLAGEN TYPE I CROSSLINK, N-TELOPEPTIDES (NTX) |
| CREATININE |
| ERYTHROCYTE SEDIMENTATION RATE,NONAUTOMATED WAIVED |
| ESTRONE-3 GLUCURONIDE |
| ETHANOL (ALCOHOL) |
| FECAL OCCULT BLOOD |
| FERN TEST, SALIVA |
| FOLLICLE STIMULATING HORMONE (FSH) |
| FRUCTOSAMINE |
| 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 |
| HDL CHOLESTEROL |
| HELICOBACTER PYLORI |
| HELICOBACTER PYLORI ANTIBODIES |
| HEMATOCRIT |
| HEMOGLOBIN |
| HEMOGLOBIN BY COPPER SULFATE, NONAUTOMATED |
| HGB, SINGLE ANALYTE INST. W/SELF-CONT... |
| HIV ANTIBODIES |
| HIV-1 AND HIV-2 ANTIBODIES |
| HIV-1 ANTIBODY |
| INFECTIOUS MONONUCLEOSIS ANTIBODIES (MONO) |
| INFLUENZA A/B |
| INFLUENZA B |
| KETONE, BLOOD |
| KETONE, URINE |
| LACTIC ACID (LACTATE) |
| LUTEINIZING HORMONE (LH) |
| LYME DISEASE ANTIBODIES (BORRELIA BURGDORFERI ABS) |
| METHAMPHETAMINE/AMPHETAMINE |
| METHAMPHETAMINES |
| METHYLENEDIOXYMETHAMPHETAMINE (MDMA) |
| MICROALBUMIN |
| MORPHINE |
| NICOTINE AND/OR METABOLITES |
| OPIATES |
| OVULATION TEST (LH) BY VISUAL COLOR COMPARISON |
| PH |
| PHENCYCLIDINE (PCP) |
| PROTHROMBIN TIME (PT) |
| RESPIRATORY SYNCYTIAL VIRUS |
| SEMEN |
| SPUN MICROHEMATOCRIT |
| STREPTOCOCCUS, GROUP A |
| THYROID STIMULATING HORMONE (TSH) |
| TRIGLYCERIDE |
| 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 |
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Database Updated 10/05/2004
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