Recognition List Number: 030 Publication Date: 01/15/2013
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 7-238: CLSI MM06-A2, Quantitative Molecular Methods for Infectious Diseeases; Approved Guideline - Second Edition. (InVitro Diagnostics)
Date of Standard: 2010. |
| Address of Standards Organization: |
| Clinical Laboratory Standards Institute (CLSI) |
| 950 West Valley Road |
| Suite 2500 |
| Wayne, PA 19087 |
| |
|
| CDRH Office and Division Associated with Recognized Standards: |
| OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR) |
|
|
| Devices Affected: |
| Quantitative Molecular IVDs for Infectious Diseases |
|
| Processes Affected: |
|
| Type of Standard: |
| Horizontal, National, Test Methods |
| Extent of Recognition: |
|
| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| Unclassified |
Assay,Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus |
Class 3 |
MZP |
| Unclassified |
Cytomegalovirus (Cmv) Dna Quantitative Assay |
Class 3 |
PAB |
| Unclassified |
Hepatitis Viral B Dna Detection |
Class 3 |
MKT |
| Unclassified |
Monitor,Test,Hiv-1 |
Class 3 |
MTL |
| Unclassified |
Test, Hiv Detection |
Class 3 |
MZF |
| |
|
| Relevant Guidance: |
| There is no relevant guidance developed at this time. |
|
| FDA Technical Contacts: |
|
|
| Li Li, MS |
| FDA/CDRH/OIVD |
| 10903 New Hampshire Avenue Building 66, Room 5558 |
| Silver Spring MD 20993 |
| 301/796-6200 |
| Email: li.li2@fda.hhs.gov |
|
|
