Recognized standard
LIS02-A2
FDA recognition 7-336 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-336 |
|---|---|
| Designation | LIS02-A2 |
| Title | Standard Specification for Transferring Information Between Clinical Instruments and Computer Systems; Approved Standard-Second Edition. |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | May 26, 2025 |
| Device classes | Class 1 |
| Scope (excerpt) | This specification covers the two-way digital transmission of remote requests and results between clinical instruments and computer systems. It enables any two such systems to establish a logical link for communicating text to send result, request, or demographic information in a standard and… |
At a glance
- None Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: