Recognition List Number: 029 Publication Date: 08/20/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 7-148: CLSI M28-A2, Procedures for the Recovery and Identification of Parasites from the Intestinal Tract; Approved Guideline - Second Edition. (InVitro Diagnostics)
Date of Standard: 2005. |
| Address of Standards Organization: |
| Clinical Laboratory Standards Institute (CLSI) |
| 950 West Valley Road |
| Suite 2500 |
| Wayne, PA 19087 |
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| CDRH Office and Division Associated with Recognized Standards: |
| OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR) |
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| Devices Affected: |
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| Processes Affected: |
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| Type of Standard: |
| Horizontal, National |
| Extent of Recognition: |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §866.3220 |
Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp. |
Class 2 |
KHW |
| §866.3220 |
Antigen, Latex Agglutination, Entamoeba Histolytica & Rel. Spp. |
Class 2 |
GMO |
| §866.3220 |
Cryptosporidium Spp. |
Class 2 |
MHJ |
| §866.3220 |
Giardia Spp. |
Class 2 |
MHI |
| §866.3220 |
Indirect Fluorescent Antibody Test, Entamoeba Histolytica & Rel Sp |
Class 2 |
GWD |
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| Relevant Guidance: |
| There is no relevant guidance developed at this time. |
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| FDA Technical Contact: |
| Raquel Peat |
| FDA/CDRH/OIVD |
| 10903 New Hampshire Avenue Building 66, Room 5561 |
| Silver Spring MD 20993 |
| 301/796-6218 |
| Email: raquel.peat@fda.hhs.gov |
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