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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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ETI-MAK-2 PLUS - 08056771102377

No Description
DIASORIN SPA
P001932
In Commercial Distribution

  • 08056771102377 ()


  • Hepatitis B virus surface antigen IVD, kit, enzyme immunoassay (EIA)

Alinity - 00380740136772

Alinity s HBsAg Calibrator Kit
Abbott Ireland Diagnostics
06P0204
In Commercial Distribution

  • 00380740136772 ()
06P0204

  • Hepatitis B virus surface antigen IVD, calibrator

Alinity - 00380740131364

Alinity i HAVAb IgG Controls
Abbott GmbH
08P2710
In Commercial Distribution

  • 00380740131364 ()
08P2710

  • Hepatitis B virus core antigen IVD, calibrator

HBsAg Confirmatory Test - E125N014308

No Description
DIASORIN SPA
N0143
In Commercial Distribution

  • E125N014308 ()


  • Hepatitis B virus surface antigen IVD, kit, enzyme immunoassay (EIA)

Aptima® - 15420045506756

Aptima® HBV Quant Assay Calibrator.
Hologic, Inc.
KIT, CALIBRATOR, HBV VL, US IVD
In Commercial Distribution

  • 15420045506756 ()
PRD-03872

  • Hepatitis B virus nucleic acid IVD, calibrator

Alinity m - 00884999047808

Alinity m HBV CAL Kit
ABBOTT MOLECULAR INC.
08N47-075
In Commercial Distribution

  • 00884999047808 ()
08N47-075

  • Hepatitis B virus nucleic acid IVD, calibrator

RealTime - 00884999003057

Abbott RealTime HBV Calibrator Kit
ABBOTT MOLECULAR INC.
2N40-70
In Commercial Distribution

  • 00884999003057 ()
2N40-70

  • Hepatitis B virus nucleic acid IVD, calibrator

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

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

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

ADVIA Centaur aHBe2 QC KIT - 00630414167947

Anti-HBe2 (aHBe2) – ADVIA Centaur – QC Kit
Siemens Healthcare Diagnostics Inc.
10720832
In Commercial Distribution

  • 00630414167947 ()
10720832

  • Hepatitis B virus e-antigen total antibody 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

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

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

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

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

Atellica IM aHBe2 QC - 00842768022685

Anti-HBe2 (aHBe2) – Atellica IM – QC Kit
Siemens Healthcare Diagnostics Inc.
10733022
In Commercial Distribution

  • 00842768022685 ()
10733022

  • Hepatitis B virus e-antigen 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

Alethia™ Group B Streptococcus External Control Kit - 00840733102110

The Alethia GBS External Control Kit contains Positive and Negative Control Reagents for use with the Alethia Group B Streptococcus test kit. External controls are used as part of a routine quality control program.
MERIDIAN BIOSCIENCE, INC.
479900
In Commercial Distribution

  • 00840733102110 ()
479900

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

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

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

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
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