| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
051
|
Date of Entry 01/14/2019
|
|
FR Recognition Number
|
7-178
|
| Standard | |
| CLSI M22-A3 Vol 24 No. 19 Replaces M22-A2 Vol. 16 No. 16 Quality Control for Commercially Prepared Microbiological Culture Media; Approved Standard - Third Edition |
|
Scope/Abstract| This standard contains quality assurance procedures for manufacturers and users of prepared, ready-to-use microbiological culture media. |
|
| Extent of Recognition
|
Rationale for Recognition
| This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. |
|
Public Law, CFR Citation(s) and Procode(s)*
| 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 |
| §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 |
| §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 |
| §866.2300 |
Culture Media, Non-Selective And Non-Differential |
Class 1 |
JSG |
| §866.2330 |
Culture Media, Enriched |
Class 1 |
KZI |
| §866.2410 |
Culture Media, For Isolation Of Pathogenic Neisseria |
Class 2 |
JTY |
|
| FDA Technical Contact
|
| Standards Development Organization
|
| FDA Specialty Task Group (STG)
|
|
|
| *These are provided as examples and others may be applicable. |
