New FDA Waived Tests
September 1, 2005The following tests are approved by the FDA as waived tests under the CLIA.
| CPT Code | Modifier Effective Date | Description |
| 86318QW | December 09, 2004 | Germaine Laboratories, Aimstep H. pylori {whole blood} |
| 87807QW | January 28, 2005 | Binax Now RSV Test (K032166/A005) |
| 81003QW | February 18, 2005 | Physician Sales & Service, Inc. PSS Select Urine Analyzer |
| 87880QW | March 08, 2005 | McKesson Medi-Lab Performance Strep A Test Dipstick |
| 86308QW | March 08, 2005 | Clearview Mono-Plus II |
| 86318QW | March 08, 2005 | Wampole Laboratories Clearview H. pylori II (finger stick or whole blood) |
| 87899QW | March 16, 2005 | Genzyme OSOM Trichomonas Rapid Test |
| 86308QW | March 16, 2005 | McKesson Medi-lab Performance Infectious Mononucleosis Test |
| 83721QW | March 25, 2005 | Polymer Technology Systems Cardiochek PA Analyzer |
| 87880QW | April 21, 2005 | Biotechnostix Rapid Response Strep A Rapid Test Strip |
| 87880QW | April 21, 2005 | Biotechnostix Rapid Response Strep A Rapid Test Device |
| 87880QW | April 21, 2005 | RAC Medical Clarity Strep A Rapid Test Strips |
| 80101QW | June 03, 2005 | Acon One Step Multi-Drug, Multi-Line Screen Test Device (Professional Use) |
Note: The tests mentioned on the first page of the Attachment included with CR3984 (i.e., CPT codes: 81002, 81025, 82270, G0107, 82962, 83026, 84830, 85013, and 85651) do not require a QW modifier to be recognized as a waived test.