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illumigene Group B Streptococcus External Control Kit - 00840733101311

The illumigene GBS External Control Kit contains Positive and Negative Control Reagents for use with the illumigene Group B Streptococcus test kit. External controls are used as part of a routine quality control program.
MERIDIAN BIOSCIENCE, INC.
279900
Not in Commercial Distribution

  • 00840733101311 ()
279900

  • Beta-haemolytic Group B Streptococcus nucleic acid IVD, control

VITROS - 10758750001972

VITROS Immunodiagnostic Products Anti-HBs Quantitative Controls
ORTHO CLINICAL DIAGNOSTICS
6802093
In Commercial Distribution

  • 10758750001972 ()
  • 20758750001979 ()
6802093

  • Hepatitis B virus surface total antibody IVD, control

Exact Diagnostics - 03610522384389

GBS Positive Run Control
EXACT DIAGNOSTICS, LLC
12020069
In Commercial Distribution

  • 03610522384389 ()
12020069

  • Beta-haemolytic Group B Streptococcus nucleic acid IVD, control

LIAISON® XL MUREX Anti-HBs Verifiers - 08056771103466

No Description
DIASORIN SPA
318223
In Commercial Distribution

  • 08056771103466 ()


  • Hepatitis B virus surface total antibody IVD, control

LIAISON® XL MUREX Control Anti-HBs - 08056771103459

No Description
DIASORIN SPA
318221
In Commercial Distribution

  • 08056771103459 ()


  • Hepatitis B virus surface total antibody IVD, control

LIAISON XL MUREX Control Anti-HBe - 08056771103435

No Description
DIASORIN SPA
318161
In Commercial Distribution

  • 28056771103439 ()
  • 08056771103435 ()


  • Hepatitis B virus e-antigen total antibody IVD, control

NATtrol™ - 01220000260153

The NATtrol™ Group B Streptococcus (GBS) Negative Control is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from this organism. The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic errors. NATtrol™ GBS Negative Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. The control does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures.
ZEPTOMETRIX CORPORATION
NATtrol™ Group B Streptococci Negative Control
In Commercial Distribution

  • 01220000260153 ()
NATLAC-6MC-IVD

  • Beta-haemolytic Group B Streptococcus nucleic acid IVD, control

NATtrol™ - 01220000260146

The NATtrol™ Group B Streptococcus (GBS) Positive Control is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from this organism. The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic errors. NATtrol™ GBS Positive Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. The control does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures.
ZEPTOMETRIX CORPORATION
NATtrol™ Group B Streptococci Positive Control
In Commercial Distribution

  • 01220000260146 ()
NATSAG-6MC-IVD

  • Beta-haemolytic Group B Streptococcus nucleic acid IVD, control

Inocu Swabs - 10634853001265

Group B Strep Positive
MICROBIOLOGICS INC.
GBS-01
In Commercial Distribution

  • 10634853001265 ()
GBS-01

  • Beta-haemolytic Group B Streptococcus nucleic acid IVD, control

Influenza B IgG Control - B110IBG21200

No Description
Bion Enterprises, Ltd.
IBG-2120
In Commercial Distribution

  • B110IBG21200 ()
IBG-2120

  • Influenza B virus immunoglobulin G (IgG) antibody IVD, control

Influenza B Negative Control - B110IBN21100

No Description
Bion Enterprises, Ltd.
IBN-2110
In Commercial Distribution

  • B110IBN21100 ()
IBN-2110

  • Influenza B virus immunoglobulin G (IgG) antibody IVD, control

QC Sets and Panels: Helix Elite™ - 70845357044197

QC Sets and Panels: Helix Elite™ Rapid Group B Streptococcus (GBS) Verification Panel
MICROBIOLOGICS INC.
8258
In Commercial Distribution

  • 70845357044197 ()
8258

  • Beta-haemolytic Group B Streptococcus nucleic acid IVD, control

QC Sets and Panels: Helix Elite™ - 70845357044180

QC Sets and Panels: Helix Elite™ Rapid Group B Streptococcus (GBS) Control Panel
MICROBIOLOGICS INC.
8242
In Commercial Distribution

  • 70845357044180 ()
8242

  • Beta-haemolytic Group B Streptococcus nucleic acid IVD, control

QC Sets and Panels: Helix Elite™ - 70845357042735

QC Sets and Panels: Helix Elite™ Group B Streptococcus (GBS) Control Panel (Inactivated Swab)
MICROBIOLOGICS INC.
8232
In Commercial Distribution

  • 70845357042735 ()
8232

  • Beta-haemolytic Group B Streptococcus nucleic acid IVD, control

QC Sets and Panels: Helix Elite™ - 70845357041219

Assayed GBS LB Control Panel
MICROBIOLOGICS INC.
8194 Cepheid Xpert® GBS LB Control Panel
Not in Commercial Distribution

  • 70845357041219 ()
8194

  • Beta-haemolytic Group B Streptococcus nucleic acid IVD, control

VIROTROL - 00847661002611

VIROTROL IV (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
00111
In Commercial Distribution

  • 00847661002611 ()
00111

  • Hepatitis B virus e-antigen total antibody IVD, control

ADVIA Centaur® Systems aHBs2 MCM - 00630414555300

aHBs2 Master Curve Material
Siemens Healthcare Diagnostics Inc.
10285962
In Commercial Distribution

  • 00630414555300 ()
4800387

  • Hepatitis B virus surface total antibody IVD, control

Atellica™ IM aHBs2 MCM - 00630414600512

aHBs2 - Atellica IM - Master Curve Material Kit 5 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995667
In Commercial Distribution

  • 00630414600512 ()
10995667

  • Hepatitis B virus surface total antibody IVD, control

Quidel Molecular - 30014613311164

QMol GBS Control Set
DIAGNOSTIC HYBRIDS, INC.
M116
In Commercial Distribution

  • 30014613311164 ()
M116

  • Beta-haemolytic Group B Streptococcus nucleic acid IVD, control

Panther Fusion® - 15420045510906

Panther Fusion® GBS Controls Kit.
Hologic, Inc.
KIT, GBS CONTROLS, FUSION, IVD
In Commercial Distribution

  • 15420045510906 ()
PRD-04485

  • Beta-haemolytic Group B Streptococcus nucleic acid IVD, control

Fungal Serology - 10634853000022

Blastomyces dermatitidis Antigen (A), 2mL ID/EXO
MICROBIOLOGICS INC.
200250
Not in Commercial Distribution

  • 10634853000022 ()
200250

  • Blastomyces dermatitidis exoantigen IVD, control

Fungal Serology - 10634853000015

Blastomyces dermatitidis Antigen (A), 1mL
MICROBIOLOGICS INC.
200125
Not in Commercial Distribution

  • 10634853000015 ()
200125

  • Blastomyces dermatitidis total antibody IVD, control

N/A - 00382903492091

BD® CD19 (4G7) PE
Becton, Dickinson And Company
349209
In Commercial Distribution

  • 00382903492091 ()
349209

  • Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)

Bordetella Pertussis IgG - 07290016332636

Bordetella Pertussis IgG kit is an Enzyme Linked Immunosorbent assay (ELISA) for the qualitative detection of specific IgG antibodies to Bordetella pertussis.
SAVYON DIAGNOSTICS LTD
A2231-01M
In Commercial Distribution

  • 07290016332636 ()
A2231-01M

  • Bordetella pertussis immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)

ALBAclone Anti-Jkb (Monoclonal) - 05060242472510

This Anti-Jkb reagent is for the in vitro detection and identification of the human Jkb blood group antigen by direct agglutination.
ALBA BIOSCIENCE LIMITED
Z168U
In Commercial Distribution

  • 05060242472527 ()
  • 05060242472510 ()
  • 05060242472534 ()


  • Anti-Jk^b red blood cell grouping IVD, antibody

ALBAclone® Anti-Fyb (Human/Murine Monoclonal) - 05060242471780

The Anti-Fyb reagent is for the in vitro detection and identification of human Fyb positive red blood cells by direct agglutination.
ALBA BIOSCIENCE LIMITED
Z154U
In Commercial Distribution

  • 05060242471780 ()


  • Anti-Fy^b red blood cell grouping IVD, antibody

ALBAclone Anti-Jkb (Monoclonal) - 05060242471711

This Anti-Jkb reagent is for the in vitro detection and identification of the human Jkb blood group antigen by direct agglutination.
ALBA BIOSCIENCE LIMITED
Z166U
In Commercial Distribution

  • 05060242471711 ()


  • Anti-Jk^b red blood cell grouping IVD, antibody

ALBAclone Anti-Lub - 05060242471032

Blood Grouping Reagent, ALBAclone Anti-Lub (Murine Monoclonal IgG) for tube technique.
ALBA BIOSCIENCE LIMITED
Z223U
In Commercial Distribution

  • 05060242471032 ()


  • Anti-Lu^b red blood cell grouping IVD, antibody

ALBAsera Anti-Fyb - 05060242470981

Blood Grouping Reagent, ALBAsera Anti-Fyb (Polyclonal) for indirect antiglobulin test by tube technique.
ALBA BIOSCIENCE LIMITED
Z153U
Not in Commercial Distribution

  • 05060242470981 ()


  • Anti-Fy^b red blood cell grouping IVD, antibody

Anti-Kpb - 00858400005039

Blood Grouping Reagent
AMERICAN NATIONAL RED CROSS
510205
In Commercial Distribution

  • 00858400005039 ()


  • Anti-Kp^b red blood cell grouping IVD, antibody

ORTHOTM Sera Anti-Jkb - 10758750013036

The Anti-Jkb reagent (Anti-JK2) is for the qualitative in vitro detection of human Jkb positive red blood cells by the direct agglutination test.
ALBA BIOSCIENCE LIMITED
6904549
In Commercial Distribution

  • 10758750013036 ()


  • Anti-Jk^b red blood cell grouping IVD, antibody

ORTHOTM Sera Anti-Fyb - 10758750013012

The Anti-Fyb reagent (Anti-FY2) is for the qualitative in vitro detection of human Fyb positive red blood cells by the indirect antiglobulin test.
ALBA BIOSCIENCE LIMITED
6904547
In Commercial Distribution

  • 10758750013012 ()


  • Anti-Fy^b red blood cell grouping IVD, antibody

ORTHO - 10758750004188

Anti-Fyb (Anti-Duffy B)
ORTHO-CLINICAL DIAGNOSTICS, INC.
725230
In Commercial Distribution

  • 10758750004188 ()
725230

  • Anti-Fy^b red blood cell grouping IVD, antibody

BIOCLONE - 10758750004157

Anti-Jkb (Monoclonal) BioClone
ORTHO-CLINICAL DIAGNOSTICS, INC.
721480
In Commercial Distribution

  • 10758750004157 ()
721480

  • Anti-Jk^b red blood cell grouping IVD, antibody

VITROS - 10758750001231

VITROS Immunodiagnostic Products Anti-HBc Controls
ORTHO CLINICAL DIAGNOSTICS
6801430
In Commercial Distribution

  • 10758750001231 ()
  • 20758750001238 ()
6801430

  • Hepatitis B virus core total antibody IVD, control

LIAISON® XL MUREX Anti-HBs - 08056771103442

No Description
DIASORIN SPA
318220
In Commercial Distribution

  • 08056771103442 ()


  • Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay

LIAISON XL MUREX Anti-HBe - 08056771103428

No Description
DIASORIN SPA
318160
In Commercial Distribution

  • 18056771103425 ()
  • 08056771103428 ()


  • Hepatitis B virus e-antigen total antibody IVD, kit, chemiluminescent immunoassay

LIAISON® XL MUREX Control Anti-HBc - 08056771103374

No Description
DIASORIN SPA
318131
In Commercial Distribution

  • 08056771103374 ()
  • 28056771103378 ()


  • Hepatitis B virus core total antibody IVD, control

PreciControl Release Anti-HBc II - 07613336183021

No Description
Roche Diagnostics GmbH
09367039190
In Commercial Distribution

  • 07613336183021 ()
09367039190

  • Hepatitis B virus core total antibody IVD, control

PreciControl Anti-HBc II - 07613336183199

No Description
Roche Diagnostics GmbH
04927931162
In Commercial Distribution

  • 07613336183199 ()
04927931162

  • Hepatitis B virus core total antibody IVD, control
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