US · guidance
CMS SOM App. C, Tag D5415
§493.1252 Standard: Test systems, equipment, instruments, reagents,
materials, and supplies.
(c) Reagents, solutions, culture media, control materials, calibration materials, and
other supplies, as appropriate, must be labeled to indicate the following:
(1) Identity and when significant, titer, strength or concentration.
(2) Storage requirements.
(3) Preparation and expiration dates.
Interpretive Guidelines §493.1252(c)(3)
Expiration dates for test kits and/or reagents may differ due to date opened or storage
conditions (e.g., refrigerator, room temperature). Verify that laboratory personnel are
aware of these differences and document the appropriate expiration date.
(4) Other pertinent information required for proper use.
History
Rev. 233; Issued: 09-12-25; Effective: 09-12-25; Implementation: 09-12-25
Provenance
- Source
- cms.gov
- Retrieved
- 2026-07-22
- Edition
- som-2026-07-22
- Content hash
78b8b5e3c254adaf225c6940b1806a6aa973ddf464041919e68c39d9791e97ee
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