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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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IMAGEN Influenza Virus A and B - 05032384502981

No Description
OXOID LIMITED
K610511-2
In Commercial Distribution

  • 05032384502981 ()


  • Influenza A/B virus antigen IVD, kit, fluorescent immunoassay

NA - 05032384005895

No Description
OXOID LIMITED
CT0044B
In Commercial Distribution

  • 05032384005895 ()
  • 05032384501946 ()


  • Polymixin B susceptibility testing disc IVD

Trinity Biotech - 05391516748780

Uni-Gold™ C. difficile Toxin A/B Controls, 1 Positive and 1 Negative
MARDX DIAGNOSTICS, INC.
1206631
In Commercial Distribution

  • 05391516748780 ()
1206631

  • Clostridium difficile toxin A/B antigen IVD, control

Trinity Biotech - 05391516747936

Clostridium difficile Toxin Control, 1.0 mL
MARDX DIAGNOSTICS, INC.
B1029-70A
In Commercial Distribution

  • 05391516747936 ()
B1029-70A

  • Clostridium difficile toxin A/B antigen IVD, control

VIROTROL - 00847661002840

VIROTROL HBc-IgM (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
00143
In Commercial Distribution

  • 00847661002840 ()
00143

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control

cobas® Influenza A/B Quality Control Kit for use on the cobas® Liat® System - 00875197005639

No Description
Roche Molecular Systems, Inc.
07402660190
In Commercial Distribution

  • 00875197005639 ()
07402660190

  • Influenza A/B virus nucleic acid IVD, control

MAS anti-HBs Positive Control - 00884883007529

No Description
Microgenics Corporation
10027482
In Commercial Distribution

  • 00884883007529 ()


  • Hepatitis B virus antigen/antibody marker IVD, control

Acrometrix AntiHBs - 00884883006942

No Description
Microgenics Corporation
960855
Not in Commercial Distribution

  • 00884883006942 ()


  • Hepatitis B virus antigen/antibody marker IVD, control

MAS anti-HBs Positive Control – For use with Siemens Assays - 00884883007383

No Description
Microgenics Corporation
10027482-U
In Commercial Distribution

  • 00884883007383 ()


  • Hepatitis B virus antigen/antibody marker IVD, control

Acrometrix HBV High Control - 00884883006553

No Description
Microgenics Corporation
965003
In Commercial Distribution

  • 00884883006553 ()


  • Hepatitis B virus antigen/antibody marker IVD, control

Acrometrix HBV Mid Control - 00884883006508

No Description
Microgenics Corporation
965002
In Commercial Distribution

  • 00884883006508 ()


  • Hepatitis B virus antigen/antibody marker IVD, control

Acrometrix HBV Low Control - 00884883006492

No Description
Microgenics Corporation
965001
In Commercial Distribution

  • 00884883006492 ()


  • Hepatitis B virus antigen/antibody marker IVD, control

Acrometrix BB NAT HBV Positive Control - 00884883006027

No Description
Microgenics Corporation
963603
In Commercial Distribution

  • 00884883006027 ()


  • Hepatitis B virus antigen/antibody marker IVD, control

Alinity - 00380740167455

Alinity s Anti-HBc Calibrator Kit
Abbott GmbH
06P0603
In Commercial Distribution

  • 00380740167455 ()
06P0603

  • Hepatitis B virus core total antibody IVD, calibrator

ORTHO - 10758750005338

ORTHO® HBc ELISA Test System
ORTHO-CLINICAL DIAGNOSTICS, INC.
933275
In Commercial Distribution

  • 10758750005338 ()
933275

  • Hepatitis B virus core total antibody IVD, kit, enzyme immunoassay (EIA)

ORTHO - 10758750005321

ORTHO® HBc ELISA Test System
ORTHO-CLINICAL DIAGNOSTICS, INC.
933245
In Commercial Distribution

  • 10758750005321 ()
933245

  • Hepatitis B virus core total antibody IVD, kit, enzyme immunoassay (EIA)

LIAISON XL MUREX Control HBcIgM - 08056771103398

No Description
DIASORIN SPA
318141
In Commercial Distribution

  • 28056771103392 ()
  • 08056771103398 ()


  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control

ETI-AB-COREK PLUS - 08056771102322

No Description
DIASORIN SPA
P001927
In Commercial Distribution

  • 08056771102322 ()


  • Hepatitis B virus core total antibody IVD, kit, enzyme immunoassay (EIA)

NATtrol™ - 01220000260085

The NATtrol™ Influenza A/B 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 these organisms. 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™ Influenza A/B 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™ Influenza A/B Positive Control
In Commercial Distribution

  • 01220000260085 ()
NATFLUAB-6C-IVD

  • Influenza A/B virus nucleic acid IVD, control

NATtrol™ - 01220000260078

The NATtrol™ Influenza/RSV 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 these organisms. 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™ Influenza/RSV 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™ Influenza/RSV Negative Control
In Commercial Distribution

  • 01220000260078 ()
NATCXVA9-6C-IVD

  • Influenza A/B virus nucleic acid IVD, control

Fluoro-CheckTM Influenza A+B - 00895160002526

An in vitro diagnostic test for the detection of influenza A and influenza B viral nucleoprotein antigens from nasopharyngeal secretion specimens in symptomatic patients.
NANO-DITECH CORPORATION
TF8147
In Commercial Distribution

  • 00895160002526 ()
  • 10895160002523 ()
TF8147

  • Influenza A/B virus antigen IVD, kit, fluorescent immunoassay

ID NOW Influenza A & B 2 Control Swab Kit - 10811877011221

Control Swabs intended for use only with the ID NOW Influenza A & B 2 product.
Alere Scarborough, Inc.
425-080
In Commercial Distribution

  • 10811877011221 ()


  • Influenza A/B virus nucleic acid IVD, control

Alere™ i Influenza A & B Control Swab Kit - 10811877010811

Control Swabs intended for use only with the Alere i Inuenza A & B product.
Alere Scarborough, Inc.
425-080
Not in Commercial Distribution

  • 10811877010811 ()


  • Influenza A/B virus nucleic acid IVD, control

ID NOW Influenza A & B Control Swab Kit - 10811877010439

Control Swabs intended for use only with the ID NOW Influenza A & B product.
Alere Scarborough, Inc.
425-080
Not in Commercial Distribution

  • 10811877010439 ()


  • Influenza A/B virus nucleic acid IVD, control

ACCURUN® - 00816784020345

ACCURUN 125 Anti-HBs 1 x 5.0 mL
Lgc Clinical Diagnostics, Inc.
2015-0077
In Commercial Distribution

  • 00816784020345 ()
2015-0077

  • Hepatitis B virus antigen/antibody marker IVD, control

ACCURUN® - 00816784020314

ACCURUN 120 HAV IgG 1 x 5.0 mL
Lgc Clinical Diagnostics, Inc.
2015-0073
In Commercial Distribution

  • 00816784020314 ()
2015-0073

  • Hepatitis B virus antigen/antibody marker IVD, control

ACCURUN® - 00816784020284

ACCURUN 115 Hepatitis B Core IgG 1 x 5.0 mL
Lgc Clinical Diagnostics, Inc.
2015-0070
In Commercial Distribution

  • 00816784020284 ()
2015-0070

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

ACCURUN® - 00816784020277

ACCURUN 113 Hepatitis B Core IgM 1 x 5.0 mL
Lgc Clinical Diagnostics, Inc.
2015-0068
In Commercial Distribution

  • 00816784020277 ()
2015-0068

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control

ACCURUN® - 00816784021007

No Description
Lgc Clinical Diagnostics, Inc.
2000-0071
In Commercial Distribution

  • 00816784021007 ()


  • Hepatitis B virus antigen/antibody marker IVD, control

ACCURUN® - 00816784020208

ACCURUN 52 Multi-Marker Hepatitis 2 6 x 3.5 mL
Lgc Clinical Diagnostics, Inc.
2000-0043
In Commercial Distribution

  • 00816784020208 ()
2000-0043

  • Hepatitis B virus antigen/antibody marker IVD, control
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