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For in vitro diagnostic use as a control to monitor the performance of multi- parameter hematology instruments. Boule Con-Diff Tri-Level is prepared from stabilized human blood so that repeated measurements can be made daily to monitor the performance of hematology analyzer systems. ASSIGNED VALUES and EXPECTED RANGES are determined on systems using specific Boule reagents. ASSIGNED VALUES are confirmed by multiple analysis of the control product.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
6 x 4.5mL
In Commercial Distribution
- 00812137010216 ()
- 00812137011794 ()
501-605
- Full blood count IVD, control
The SeCore CDx HLA Sequencing System is an in-vitro diagnostic intended to be used as a companion diagnostic for the qualitative detection of HLA alleles to aid in the selection of patients to receive specific medicinal products.
ONE LAMBDA, INC.
SECCDX-GSSP
In Commercial Distribution
- 00812117016825 ()
SECCDX-GSSP
- HLA class I & II antigen tissue typing IVD, kit, multiplex
The SeCore CDx HLA Sequencing System is an in-vitro diagnostic intended to be used as a companion diagnostic for the qualitative detection of HLA alleles to aid in the selection of patients to receive specific medicinal products.
ONE LAMBDA, INC.
SECCDX-A
In Commercial Distribution
- 00812117016818 ()
SECCDX-A
- HLA class I & II antigen tissue typing IVD, kit, multiplex
Freezing Medium Test Yolk Buffer (TYB) with Glycerol and Gentamicin
IRVINE SCIENTIFIC, LLC
90128-20x5ML
In Commercial Distribution
- 00810195240163 ()
90128
- IVF medium
Refrigeration Medium - Test Yolk Buffer (TYB) with Gentamicin
IRVINE SCIENTIFIC, LLC
90129-20x5ML
In Commercial Distribution
- 00810195240156 ()
90129
- IVF medium
ACCURUN 146 CMV IgM Positive Control 1 x 1.0 mL
Lgc Clinical Diagnostics, Inc.
2015-0088
In Commercial Distribution
- 00816784020444 ()
2015-0088
- Cytomegalovirus (CMV) antigen IVD, control
ACCURUN 132 Borrelia burgdorferi IgM 1 x 1.0 mL
Lgc Clinical Diagnostics, Inc.
2015-0081
In Commercial Distribution
- 00816784020383 ()
2015-0081
- Borrelia burgdorferi immunoglobulin M (IgM) antibody IVD, control
MassTrak™ Steroid Internal Standard Mix
WATERS TECHNOLOGIES CORPORATION
186010567IVD
In Commercial Distribution
- 00816776020599 ()
186010567IVD
- Multiple steroid hormone IVD, control
MassTrak™ Steroid Optimization Mix
WATERS TECHNOLOGIES CORPORATION
186010568IVD
In Commercial Distribution
- 00816776020582 ()
186010568IVD
- Multiple steroid hormone IVD, control
MassTrak™ Steroid Serum Cal Set 3
WATERS TECHNOLOGIES CORPORATION
186010565IVD
In Commercial Distribution
- 00816776020568 ()
186010565IVD
- Multiple steroid hormone IVD, control