Menstuff® has compiled the following information on self
testing of medical conditions. Some states, like California and
Oregon, still require a doctor's "permission" to have a
philodist draw your blood.
Over-the-Counter In Vitro Diagnostic Devices
The names of the devices or manufacturers may have changed since the devices were cleared. The names listed are those submitted in the pre-market applications unless the applicants notified the FDA of a change.
Some of the devices may never have been marketed or may not be marketed today.
"Over-the-Counter" is not synonymous with "Waived Status" in regard to the Clinical Laboratories Improvement Amendments of 1988 (CLIA-88). Contact Ms. Clara Sliva at 301.827.0496 for information regarding the Waived status of these devices.
The list does not include devices that may be available for home use by prescription only. It also does not include any tests such as HIV that are reviewed by the Center for Biologics Evaluation and Research (CBER).
In the chart, the Test Codes column refers to the tests listed below. The FDA Product Codes column refers to codes used by FDA and device manufacturers for regulatory purposes; i.e. medical device listing and medical device reporting.
Explanation of Test Codes:
GLU - Glucose (whole blood) UBI - Bilirubin (urine)
CHO - Cholesterol (whole blood) UCA - Catalase (urine)
HDL - High Density Lipoprotein (whole blood) UCL - Chloride (urine)
TRG - Triglycerides (whole blood) UCR - Creatinine (urine)
GHB - Glycosylated Hemoglobin (whole blood) UGL - Glucose (urine)
FRU - Fructosamine (whole blood) UKE - Ketones (urine)
KET - Ketones (whole blood) UNI - Nitrites (urine)
HCG - Pregnancy (urine) UOC - Occult Blood (urine)
LAC - Lactate (whole blood) UPH - pH (urine)
LH - Ovulation Prediction (urine) UPR - Protein (urine)
OCC - Occult Blood (stool) UUR - Urobilinogen (urine)
COL - Collection Device (general)
SEM - Semen Analysis (semen)
DOA - Drugs of Abuse (urine)
VPH - pH (vaginal fluid)
If you need additional information, contact J. David Lyle, Division of Clinical Laboratory Devices, Office of Device Evaluation, Center for Devices and Radiological Health, 301.594.3084.
Source: www.fda.gov/cdrh/ode/otclist.html
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