Recognition List Number: 028 Publication Date: 03/16/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 7-178: CLSI M22-A3, Quality Control for Commercially Prepared Microbiological Culture Media; Approved Standard - Third Edition. (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: |
| Primary, Differential, Selective and non-selective microbiological culture media, IVDs |
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| Processes Affected: |
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| Type of Standard: |
| Horizontal, National |
| Extent of Recognition: |
| Partial: CDRH recognizes the methods used in performing the QC. However, it appears that the information is limited to a certain culture medium for "Media specifically for isolation of B. cepacia". Additionally, the incubation environmental and time vary dependent on the specific medium formulations for "Media specifically for isolation of B. pertussis" |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §866.2300 |
Culture Media, Non-Selective And Non-Differential |
Class 1 |
JSG |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §866.2320 |
Culture Media, Multiple Biochemical Test |
Class 1 |
JSE |
| §866.2320 |
Culture Media, Non-Selective And Differential |
Class 1 |
JSH |
| §866.2320 |
Culture Media, Single Biochemical Test |
Class 1 |
JSF |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §866.2330 |
Culture Media, Enriched |
Class 1 |
KZI |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §866.2350 |
Culture Media, Antibiotic Assay |
Class 1 |
JSA |
| §866.2350 |
Culture Media, General Nutrient Broth |
Class 1 |
JSC |
| §866.2350 |
Culture Media, Vitamin Assay |
Class 1 |
JSB |
| §866.2350 |
Media, Culture, Amino Acid Assay |
Class 1 |
JRZ |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §866.2360 |
Culture Media, Selective And Differential |
Class 1 |
JSI |
| §866.2360 |
Culture Media, Selective And Non-Differential |
Class 1 |
JSJ |
| §866.2360 |
Culture Media, Selective Broth |
Class 1 |
JSD |
| |
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| Relevant Guidance: |
| There is no relevant guidance developed at this time. |
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| FDA Technical Contact: |
| Alexandra Wong |
| FDA/CDRH/OIVD |
| 10993 New Hampshire Avenue Building 66, Room 5502 |
| Silver Spring MD 20993 |
| 301/796-6210 |
| Email: alexandra.wong@fda.hhs.gov |
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