XYLENE SUBSTITUTE MONTANT
Device Facts
| Record ID | K854083 |
|---|---|
| Device Name | XYLENE SUBSTITUTE MONTANT |
| Applicant | Lerner Laboratories, Inc. |
| Product Code | KEM · Pathology |
| Decision Date | Oct 22, 1985 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.4010 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A general purpose reagent is a chemical reagent that has general laboratory application, that is used to collect, prepare, and examine specimens from the human body for diagnostic purposes, and that is not labeled or otherwise intended for a specific diagnostic application. It may be either an individual substance, or multiple substances reformulated, which, when combined with or used in conjunction with an appropriate analyte specific reagent (ASR) and other general purpose reagents, is part of a diagnostic test procedure or system constituting a finished in vitro diagnostic (IVD) test. General purpose reagents are appropriate for combining with one or more than one ASR in producing such systems and include labware or disposable constituents of tests; but they do not include laboratory machinery, automated or powered systems. General purpose reagents include cytological preservatives, decalcifying reagents, fixative and adhesives, tissue processing reagents, isotonic solutions and pH buffers. Reagents used in tests for more than one individual chemical substance or ligand are general purpose reagents (e.g., Thermus aquaticus (TAQ) polymerase, substrates for enzyme immunoassay (EIA)).
