| BK251285 |
Roche Diagnostics
Indianapolis, IN 46250 |
Elecsys Syphilis |
12/10/2025 |
| BK251268 |
Synova Life Sciences, Inc.
Los Angeles, CA 90032 |
Synova Wave Adipose Processing System |
11/17/2025 |
| BK251272 |
Alba Bioscience Limited
United Kingdom |
Alba Elution Kit |
11/14/2025 |
| BK251265 |
Alba Bioscience Limited
United Kingdom |
ORTHO® Elution Kit |
11/12/2025 |
| BK251174 |
MimiX Biotherapeutics, Ltd |
FastSkin Patch |
11/07/2025 |
| BK251238 |
Ortho-Clinical Diagnostics, Inc. |
ORTHO VISION® Analyzer and ORTHO VISION® Max Analyzer |
10/10/2025 |
| BK251256 |
Immucor, Inc.
Norcross, Georgia 30071 |
ImmuLINK (v3.3) |
10/24/2025 |
| BK251237 |
Micro Typing Systems, Inc. |
DAT Control (MTSTM DAT Card) |
10/10/2025 |
| BK251280 |
Roche Diagnostics
Indianapolis, IN 46250 |
cobas pro serology solution (applicable to) Elecsys Syphilis and Elecsys Anti-CMV |
10/09/2025 |
| BK251201 |
Rmedical Co., Ltd |
DR.PRP-30 |
10/08/2025 |
| BK251157 |
B.T.I. Biotechnology Institute, S.L.
Miñano (Álava), Spain |
ENDORET® Kit |
10/03/2025 |
| BK251241 |
Haemonetics Corporation
Boston, MA 02110 |
SafeTrace Tx® Software 5.0.0 |
09/10/2025 |
| BK251196 |
StemC Biyoteknoloji Anonim Sirketi
New Smyrna Beach, FL 32168 |
Exocube Set |
08/28/2025 |
| BK251234 |
Abbott Molecular
Des Plaines, IL 60018 |
Alinity m HIV-1 AMP Kit
Alinity m HIV-1 CTRL Kit
Alinity m HIV-1 CAL Kit
Alinity m HIV-1 Application Specification File |
08/27/2025 |
| BK251254 |
Bio-Rad Laboratories, Inc
Woodinville, WA 98072 |
Geenius™ HIV 1/2 Supplemental Assay |
08/26/2025 |
| BK251199 |
EUROMI S.A
Belgium |
NLF system® kit 2 (EUROMI) |
08/14/2025 |
| BK251235 |
Roche Molecular Systems, Inc
Pleasanton, CA 94588 |
cobas® HIV-1 Quantitative nucleic acid test for use on the cobas® 5800/6800/8800 systems |
07/01/2025 |
| BK251233 |
Roche Molecular Systems, Inc
Pleasanton, CA 94588 |
cobas® HIV-1/HIV-2 Qualitative nucleic acid test for use on the cobas® 5800/6800/8800 systems |
06/27/2025 |
| BK251184 |
Diagnostic Grifols, S.A.
Barcelona, Spain |
DG Gel 8 Neutral card |
06/17/2025 |
| BK251183 |
Diagnostic Grifols, S.A.
Barcelona, Spain |
Erytra |
06/17/2025 |
| BK251182 |
Diagnostic Grifols, S.A.
Barcelona, Spain |
Erytra Eflexis |
06/17/2025 |
| BK251188 |
MAK-SYSTEM Group Ltd.
London United Kingdom |
Patient Health Software (P.H.S) v11.0.0.0 |
06/11/2025 |
| BK241116 |
DiaSorin, Inc.
Stillwater, MN |
LIAISON® MUREX HIV Ab-Ag HT and LIAISON® MUREX Control HIV Ab-Ag HT |
06/10/2025 |
| BK241079 |
Innoveren Scientific, Inc.
Cincinnati, OH |
Peripheral blood processing device for wound management |
03/28/2025 |
| BK231039 |
Delcon S.r.l.
Italy |
Giotto Monza (BCS03) |
03/26/2025 |
| BK251160 |
Fresenius Kabi AG
Lake Zurich, IL |
Adaptive Nomogram Bottle |
02/21/2025 |
| BK241136 |
BioLife Plasma Services LP
Bannockburn, IL |
Lookback Notification System version 2.0 |
02/20/2025 |
| BK241135 |
Fresenius Kabi AG
Lake Zurich, IL |
Aurora Xi Plasmapheresis System Software Version 2.0 |
01/24/2025 |
| BK231018 |
Sunphoria Co.,Ltd
Taiwan |
AHC Platelet Concentrate Separator |
01/10/2025 |
| BK241148 |
Roche Diagnostics
Indianapolis, IN |
cobas pro serology solution (applicable to)
a) Elecsys Syphilis and
b) Elecsys Anti-CMV |
01/10/2025 |
| BK210601 |
Immucor, Inc.
Norcross, GA |
Echo Lumena |
01/08/2025 |
| BK210604 |
Immucor, Inc.
Norcross, GA |
Complement Control Cells |
01/08/2025 |
| BK210608 |
Immucor, Inc.
Norcross, GA |
Galileo Echo |
01/08/2025 |
| BK241067 |
Immucor GTI Diagnostics, Inc.
Waukesha, WI |
MatchX |
01/02/2025 |
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