Recognition List Number: 028 Publication Date: 03/16/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 7-225: CLSI GP34-A, Validation and Verfication of Tubes for Venous and Capillary Blood Specimen Collection; Approved Guidance. (InVitro Diagnostics)
Date of Standard: 2011. |
| 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: |
| Any blood collection devices (may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes) intended to collect, transport, separate, and process venous blood specimens for clinical laboratory testing. |
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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 |
| §862.1675 |
Tubes, Vials, Systems, Serum Separators, Blood Collection |
Class 2 |
JKA |
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| Relevant Guidance: |
| Complementary guidance from CLSI: H1-A6 Tubes and Additives for Venous Blood Specimen Collection; Approved Standard?Sixth Edition. |
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| FDA Technical Contact: |
| Yung Chan |
| FDA/CDRH/OIVD |
| 10903 New Hampshire Avenue Building 66, Room 5630 |
| Silver Spring MD 20993 |
| 301/796-6138 |
| Email: yung.chan@fda.hhs.gov |
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