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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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VIROTROL - 00847661005421

VIROTROL II (An unassayed (human) serological control.)
BIO-RAD LABORATORIES, INC.
00115A
In Commercial Distribution

  • 00847661005421 ()
00115A

  • Multiple blood-borne virus antigen/antibody IVD, control

VIROTROL - 00847661005322

VIROTROL I (An unassayed (human) serological control.)
BIO-RAD LABORATORIES, INC.
00100B
In Commercial Distribution

  • 00847661005322 ()
00100B

  • Multiple blood-borne virus antigen/antibody IVD, control

VIROTROL - 00847661004776

VIROTROL I (An unassayed (human) serological control.)
BIO-RAD LABORATORIES, INC.
00100H
In Commercial Distribution

  • 00847661004776 ()
00100H

  • Multiple blood-borne virus antigen/antibody IVD, control

VIROTROL - 00847661004769

VIROTROL I (An unassayed (human) serological control.)
BIO-RAD LABORATORIES, INC.
00100F
In Commercial Distribution

  • 00847661004769 ()
00100F

  • Multiple blood-borne virus antigen/antibody IVD, control

VIROTROL - 00847661004752

VIROTROL I (An unassayed (human) serological control.)
BIO-RAD LABORATORIES, INC.
00100E
In Commercial Distribution

  • 00847661004752 ()
00100E

  • Multiple blood-borne virus antigen/antibody IVD, control

VIROTROL - 00847661004745

VIROTROL I (An unassayed (human) serological control.)
BIO-RAD LABORATORIES, INC.
00100G
In Commercial Distribution

  • 00847661004745 ()
00100G

  • Multiple blood-borne virus antigen/antibody IVD, control

VIROTROL - 00847661004738

VIROTROL I (An unassayed (human) serological control.)
BIO-RAD LABORATORIES, INC.
00100C
In Commercial Distribution

  • 00847661004738 ()
00100C

  • Multiple blood-borne virus antigen/antibody IVD, control

VIROTROL - 00847661004707

VIROTROL I (An unassayed (human) serological control.)
BIO-RAD LABORATORIES, INC.
00101D
In Commercial Distribution

  • 00847661004707 ()
00101D

  • Multiple blood-borne virus antigen/antibody IVD, control

VIROTROL - 00847661004684

VIROTROL III (An unassayed (human) serological control.)
BIO-RAD LABORATORIES, INC.
00110A
In Commercial Distribution

  • 00847661004684 ()
00110A

  • Multiple blood-borne virus antigen/antibody IVD, control

VIROTROL - 00847661004585

VIROTROL III (An unassayed (human) serological control.)
BIO-RAD LABORATORIES, INC.
00110C
In Commercial Distribution

  • 00847661004585 ()
00110C

  • Multiple blood-borne virus antigen/antibody IVD, control

VIROTROL - 00847661004240

VIROTROL I (An unassayed (human) serological control.)
BIO-RAD LABORATORIES, INC.
00100A
In Commercial Distribution

  • 00847661004240 ()
00100A

  • Multiple blood-borne virus antigen/antibody IVD, control

VIROCLEAR - 00847661002581

VIROCLEAR (An unassayed (human) serological control.)
BIO-RAD LABORATORIES, INC.
00107
In Commercial Distribution

  • 00847661002581 ()
00107

  • Multiple blood-borne virus antigen/antibody IVD, control

VIROCLEAR - 00847661002574

VIROCLEAR (An unassayed (human) serological control.)
BIO-RAD LABORATORIES, INC.
00112
In Commercial Distribution

  • 00847661002574 ()
00112

  • Multiple blood-borne virus antigen/antibody IVD, control

VIROCLEAR - 00847661002567

VIROCLEAR (An unassayed (human) serological control.)
BIO-RAD LABORATORIES, INC.
00106
In Commercial Distribution

  • 00847661002567 ()
00106

  • Multiple blood-borne virus antigen/antibody IVD, control

ACCURUN® 2 Series 5600 - 00860006589783

No Description
Lgc Clinical Diagnostics, Inc.
2000-0100
In Commercial Distribution

  • 00860006589783 ()


  • Multiple blood-borne virus antigen/antibody IVD, control

ACCURUN® - 00860006589776

No Description
Lgc Clinical Diagnostics, Inc.
2000-0079
In Commercial Distribution

  • 00860006589776 ()


  • Multiple blood-borne virus antigen/antibody IVD, control

ACCURUN® - 00860006589707

No Description
Lgc Clinical Diagnostics, Inc.
2000-0080
In Commercial Distribution

  • 00860006589707 ()


  • Multiple blood-borne virus antigen/antibody IVD, control

Remel - 00848838068416

Xpect C. diff Toxin A/B KT/40TST
REMEL, INC.
R24640
In Commercial Distribution

  • 30848838068417 ()
  • 00848838068416 ()


  • Clostridium difficile antigen IVD, kit, rapid ICT, clinical

Remel - 00848838027093

Xpect C. diff Toxin A/B KT/20TST
REMEL, INC.
R24650
In Commercial Distribution

  • 30848838027094 ()
  • 00848838027093 ()


  • Clostridium difficile antigen IVD, kit, rapid ICT, clinical

QUANTA Lite® PBC Screen IgG/IgA ELISA - 08426950594239

1. 1x PBC Screen IgG/IgA ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted PBC Screen IgG/IgA ELISA Low Positive 4. 1x 1.2mL prediluted PBC Screen IgG/IgA ELISA High Positive 5. 1x 50mL HRP Sample Diluent 6. 1x 25mL HRP Wash Concentrate, 40x concentrate 7. 1x 10mL HRP PBC Screen IgG/IgA Conjugate, (goat), anti-human IgG/IgA 8. 1x 10mL TMB Chromogen 9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid
INOVA DIAGNOSTICS, INC.
704560
In Commercial Distribution

  • 08426950594239 ()


  • Multiple liver disease-associated antibody IVD, kit, enzyme immunoassay (EIA)

BioSign Flu A+B Nasal Wash/Aspirate Kit - 10743816001485

BioSign Flu A+B Nasopharyngeal Wash/Aspirate Kit, 50 pipettes
PRINCETON BIOMEDITECH CORPORATION
BSP-510AS-07
In Commercial Distribution

  • 10743816001485 ()
BSP-510AS-07

  • Nasopharyngeal aspirate container IVD
  • Influenza A/B virus antigen IVD, reagent

Status Flu A+B Nasal Wash/Aspirate Kit - 10743816001416

Status Flu A+B Nasopharyngeal Wash/Aspirate Kit; 44 Pipettes
PRINCETON BIOMEDITECH CORPORATION
BSP-510AS-04
In Commercial Distribution

  • 10743816001416 ()
BSP-510AS-04

  • Nasopharyngeal aspirate container IVD
  • Influenza A/B virus antigen IVD, reagent

Status™ COVID-19/Flu Control - 10743816001614

Status™ COVID-19/Flu A&B Control Swab Kit (5 Positive/ 5 Negative)
PRINCETON BIOMEDITECH CORPORATION
BSP-511C-00
In Commercial Distribution

  • 10743816001614 ()
BSP-511C-00

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control
  • Influenza A/B virus antigen IVD, control

ACCURUN® - 00816784020123

ACCURUN 24 Multi-Marker Confirmatory Control 3 x 1.0 mL
Lgc Clinical Diagnostics, Inc.
2000-0032
In Commercial Distribution

  • 00816784020123 ()
2000-0032

  • Multiple blood-borne virus antigen/antibody IVD, control

ACCURUN® - 00816784020062

ACCURUN 1 Series 5600 Multi-Marker Positive Control 6 x 3.5 mL
Lgc Clinical Diagnostics, Inc.
2000-0018
In Commercial Distribution

  • 00816784020062 ()
2000-0018

  • Multiple blood-borne virus antigen/antibody IVD, control

ACCURUN® - 00816784020055

ACCURUN 1 Series 4400 Multi-Marker 12 x 3.5 mL
Lgc Clinical Diagnostics, Inc.
2000-0010
In Commercial Distribution

  • 00816784020055 ()
2000-0010

  • Multiple blood-borne virus antigen/antibody IVD, control

ACCURUN® - 00816784020048

ACCURUN 1 Series 4000 Multi-Marker 3 x 5.0 mL
Lgc Clinical Diagnostics, Inc.
2000-0008
In Commercial Distribution

  • 00816784020048 ()
2000-0008

  • Multiple blood-borne virus antigen/antibody IVD, control

ACCURUN® - 00816784020031

ACCURUN 1 Series 2500 Multi-Marker 12 x 3.5 mL
Lgc Clinical Diagnostics, Inc.
2000-0002
In Commercial Distribution

  • 00816784020031 ()
2000-0002

  • Multiple blood-borne virus antigen/antibody IVD, control

ACCURUN® - 00816784020024

ACCURUN 1 Series 2400 Multi-Marker 12 x 3.5 mL
Lgc Clinical Diagnostics, Inc.
2000-0001
In Commercial Distribution

  • 00816784020024 ()
2000-0001

  • Multiple blood-borne virus antigen/antibody IVD, control

ACCURUN® - 00816784020888

ACCURUN 1 Series 2700 Multi-Marker Positive Control 3 x 1 mL
Lgc Clinical Diagnostics, Inc.
2000-0006
In Commercial Distribution

  • 00816784020888 ()
2000-0006

  • Multiple blood-borne virus antigen/antibody IVD, control
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