Recognition List Number: 021 Publication Date: 03/18/2009
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 7-182: CLSI M36-A, Clinical Use and Interpretation of Serologic Tests for Toxoplasma gondii. (InVitro Diagnostics)
Date of Standard: 2004. |
| 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) | | DIVISION OF MICROBIOLOGY (DMD) |
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| Devices Affected: |
| Toxoplasma gondii Serologic devices |
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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 |
| §866.3780 |
Antigens, Cf, Toxoplasma Gondii |
Class 2 |
GMN |
| §866.3780 |
Antigens, If, Toxoplasma Gondii |
Class 2 |
GLZ |
| §866.3780 |
Antigens, Iha, Toxoplasma Gondii |
Class 2 |
GMM |
| §866.3780 |
Antisera, If, Toxoplasma Gondii |
Class 2 |
LJK |
| §866.3780 |
Direct Agglutination Test, Toxoplasma Gondii |
Class 2 |
LLA |
| §866.3780 |
Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii |
Class 2 |
LGD |
| §866.3780 |
Pneumocystis Carinii |
Class 2 |
LYF |
| |
|
| Relevant Guidance: |
| There is no relevant guidance developed at this time. |
|
| 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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