Blood FAQs- Is it true that we must label blood and blood components with specific machine-readable bar code information by April 26th, 2006?
- What machine-readable information is required for blood and blood components?
- We are a transfusion service and very infrequently prepare split units, pediatric units, and pooled cryoprecipitate units; do we need machine-readable labels for these units?
- I have questions about how to encode facility identifiers and product codes for pooled and aliquoted units for Codabar or ISBT 128? Where do I get information about these issues?
- How will FDA evaluate compliance with the rule?
- May I request an exception or alternative under 21 CFR 640.120 for this requirement of the blood and blood component container label regulations?
- Why are good blood donors being deferred because they have visited the U.K.?
- How many people have died as a result of nvCJD?
- Where can I obtain more epidemiological information or statistics regarding nvCJD?
- Is it true that individuals diagnosed with hemochromatosis can now donate?
- Is it true that individuals diagnosed with hemochromatosis can now donate?
- I was diagnosed with hepatitis at a young age. Am I still deferred?
- I was recently deferred for an inconclusive Hepatitis B core test. Can you explain the reasoning behind the deferral?
- What is the OraQuick Rapid HIV-1 Antibody Test and how is it performed?
- How well does the OraQuick Rapid HIV-1 Antibody test work?
- What are the limitations of the OraQuick Rapid HIV-1 Antibody test? Does this test always give a correct result?
- What type of counseling is done for rapid HIV tests?
- Could anyone in Europe diagnosed with the newly recognized variant of CJD (vCJD) have acquired this from vaccines?
- What temporary blood donor deferrals does FDA recommend for people who have received the smallpox vaccination?
- Are people who come in contact with individuals who have received a smallpox vaccine deferred?
- Are blood donors deferred if the vaccinia innoculation scabs are scraped off or otherwise removed?
- Does the OraQuick Rapid HIV-1 test detect antibodies to HIV-2?
- How does FDA's policy of temporarily deferring blood donors who have received a smallpox vaccine affect the blood supply?
- How can I help prevent potential blood shortages in case of widespread smallpox vaccination?
- Are blood donors allowed to be screened using the OraQuick Rapid HIV-1 test?
- Is FDA studying whether or not vaccinia may be transmitted by blood?
- Who is permitted to purchase and use the OraQuick Rapid HIV-1 test?
- Is the current Uniform Donor History Questionnaire (UDHQ) sufficient for screening donors who have received a smallpox vaccination? If not, how long do we have to implement the new question?
- Can blood establishments use an alternate question wording and/or procedures to the ones recommended by FDA for blood donors who have received a smallpox vaccination?
- Can the new donor questions about recent smallpox vaccination be asked orally, or must they be asked in writing?
- What constitutes an adequate quality assurance system in a clinical laboratory?
- OraQuick was originally approved as a moderate complexity test under CLIA. What is different now that the test is waived?
- How can I obtain a Certificate of Waiver from the CLIA program?
- How much does the OraQuick Rapid HIV-1 test cost?
- How many different HIV home tests are available in the United States, and how do they work?
- What is the difference between a test, a rapid test, test system and a home-use HIV test kit?
- What is an HIV home collection test system and how does it work?
- How are unapproved HIV test systems different?
- How reliable are HIV test kits that are not FDA approved?
- How reliable are approved HIV home collection test systems?
- What about counseling for the use of the HIV home collection test system?
- Are approved HIV collection test systems really confidential?
- Is one HIV home collection test system better than another?
- Are there other ways I can be tested for infection with HIV?
- May I request an exception or alternative under 21 CFR 640.120 for this requirement of the blood and blood component container label regulations?
- Where can I find information regarding the consent decree for the American Red Cross?
- I am a regulated entity and I cannot find the answer to my question, who can I contact for assistance?
- Where can I find a list of FDA approved tests for screening blood donors?
- Where can I find a list of tests used for scrrening donors of human cells, tissues, and cellular and tissue based products (HCT/Ps)?
- Does FDA maintain a national list of deferred blood donors?
- What constitutes a clinical laboratory?
Last revised: March 29, 2007 | 
