Panels › Clinical Toxicology › Product code DLJ · Class 2
Calibrators, Drug Specific
Regulation 862.3200
0510(k)s in 12 months (123 all time)
0recalls in 12 months (5 all time)
4recalls that name a 510(k)
Top companies in DLJ
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 30, 2023 | Ortho-Clinical Diagnostics, Inc. VITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation (GEN) 50 with affected Assay Data Disk (ADD) for Data Release Versions (DRVs) 6215 through 6223.
In vitro diagnostic -VITROS Chemis Open, Classified |
DLJ | None listed |
| Mar 12, 2014 | Lin-Zhi International Inc Cannabinoids DAU Calibrator Control Level 1
(37.5 ng/mL)
This solution is prepared from non-sterile urine and should be handled as potentially infectious.
IVD;
The Cannabinoids (cTHC also known as T Terminated |
DLJ | K021449 |
| Jan 17, 2012 | Microgenics Corp Tobramycin Calibrators, REF 7F93-01;
Microgenics Corporation, 46360 Fremont Blvd Fremont, CA 94538;
Distributed by Abbott Diagnostics, 100 Abbott Park Road, Abbott Park, Illinois 60064.
.Tobramyci Terminated |
DLJ | K872349 |
| Nov 28, 2011 | Microgenics Corp Multigent Vancomycin Calibrators;
Manufactured by Microgenics Corp, Fremont, CA.
Distributed by: Abbott Diagnostics, Abbott Park, IL
Product Usage:
The Multigent Vancomycin calibrators are intended Terminated |
DLJ | K872644 |
| Dec 16, 2010 | Abbott Laboratories ARCHITECT iVancomycin Reagent; an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of vancomycin in human serum or plasma on the ARCHITECT i System with STAT Terminated |
DLJ | K072036 |
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