What does "FDA Approved" mean?

The United States Food and Drug Administration (FDA) is the federal governmental agency charged with protecting the health and welfare of the American public through the regulation of food, drugs and medical devices, among other responsibilities. It is probably the most critical mission assigned to any of our federal governmental agencies and, as you can imagine, the FDA takes its oversight mission seriously. Its regulations are extremely stringent. Its inspections are thorough. Its penalties for non-compliance are damaging. But when you are talking about food, drugs and medical devices, you wouldn't want it any other way, would you? When we say that the test kit is FDA-Approved, it means that EVERY aspect or component of the test system, including any claim found on our kit boxes, has been scientifically proven to be valid, safe and effective. This involves extensive clinical trials with hundreds of patients, backed up by voluminous documentation and verification of the clinical trail results. It also includes a thorough FDA inspection of the laboratory and facilities in addition to intense review of the validity of the computer system's hardware and software. It is against the law for any product or service to claim it is FDA-Approved when it isn't. And when a product isn't FDA-Approved it means that FDA hasn't been afforded the opportunity to review or pass judgment on any data or science connected to a specific product's claims.

We thought you might find these product(s) useful:

• BreathScan .02% BAC Alcohol Detector Test
• Home Access® HIV Standard Test
• Home Access HIV Express Test
• Home Access Hepatitis C Test
• Home Access Instant Cholesterol Test
• Prostate Specific Antigen (PSA) Testing Service (Includes Blood Collection Kit)
• PDT 90 Basic Hair Drug Testing Kit (Individual & Parent Use)
• Pregnancy Strip Test
• Ovulation Midstream Test
• Ovulation Cassette Test
• Ovulation Strip Test
• Pregnancy Cassette Test
• Pregnancy Midstream Test
• Pregnancy Tests - 5 Pack
• Pregnancy Tests - 5 Pack
• Pregnancy Midstream Tests (5 pack)
• Sperm Check Male Fertility Sperm Count Home Test Kit
• EZ Detect Instant Home Testing Kit for Blood in Stool (Fecal Occult Blood Test - FOBT)
• Colon Alert Fecal Occult Blood Test
• Breast Self-Exam Pad
• Marijuana (THC) Cassette Urine Drug Test
• Marijuana (THC) Dip-strip Urine Drug Test
• Cassette 5 Panel Urine Test (THC / COC / mAMP / MOP / AMP)
• Cassette 6 Panel Urine Test (COC / AMP / mAMP / THC /OPI / BZO)
• Flexsite A1c-At-Home Test (Hemoglobin A1C Home Testing Kit)
• KidneyScreen At-Home Test
• Cassette 10 Panel Urine Test (COC / AMP / mAMP / THC / MTD / OPI / PCP / BAR / BZO / TCA)
• ImmuneTech MyAllergyTest Home Test Kit for Ten Most Common Allergens
• Cassette 2 Panel Urine Test (THC / COC)
• Cassette 2 Panel Urine Test (THC / MET)
• Surecheck Early Pregnancy Test 2-Pack
• Surecheck Early Pregnancy Test
• Cocaine(COC) Cassette Urine Drug Test
• Cocaine(COC) Dip-strip Urine Drug Test
• MDMA (Ecstasy) Cassette Urine Drug Test
• Opiates/Heroin (OPI) Cassette Urine Drug Test
• Opiates/Heroin (OPI) Dip-strip Urine Drug Test
• The Multi-Drug Screen Test Cup
• Ovulite Personal Ovulation Detector
• iScreen™ Immunochemical Fecal Occult Blood Test
• Pregnancy and Fertility Gift Basket
• MONO Mononucleosis Early Detection Rapid Test Strip (Whole Blood/Serum/Plasma)
• Breast Exam Shower Card
• BabyConfirm Home Pregnancy Test Kit
• BabyPrep Home Ovulation Test Kit (with Free Pregnancy Test)
• Male Cancer Screening
• Female Cancer Screening
• ALT (Liver Health Screening)
• CEA (Carcinoembryonic Antigen) Screening
• CA 27.29 Screening for Breast Cancer
• CA19-9 Screening for Cancer
• Dried Semen Stain Instant Test Kit
• Lab-Aids AIDS and STD Transmission and Control (A Simulation) Kit
• Clarity Pregnancy Urine Test Strips HCG (Box of 25)
• Clarity Pregnancy Urine Test Strips HCG (Box of 50)
• Clarity Strep-A Dip Stick Test Kit (Box of 25)

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