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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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ABBOTT PRISM - 00380740038403

ABBOTT PRISM Run Control Kit
ABBOTT LABORATORIES
3E60-10
Not in Commercial Distribution

  • 00380740038403 ()
03E6010

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

OraSure Quickflu Nasopharyngeal Wash / Aspirate - 00608337000047

No Description
Orasure Technologies, Inc.
1001-0321
In Commercial Distribution

  • 00608337000047 ()


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

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)

VIROTROL - 03610520530146

VIROTROL PLUS-R (An unassayed (human) serology control)
BIO-RAD LABORATORIES, INC.
12000539
In Commercial Distribution

  • 03610520530146 ()
12000539

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

VIROTROL - 03610520530139

VIROTROL PLUS-R (An unassayed (human) serology control)
BIO-RAD LABORATORIES, INC.
12000538
In Commercial Distribution

  • 03610520530139 ()
12000538

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

EUROLINE Profile Autoimmune Liver Disease 8 Ag (IgG) - 04049016124894

No Description
EUROIMMUN Medizinische Labordiagnostika AG
DL 1300-6401-8 G
In Commercial Distribution

  • 04049016124894 ()


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

EUROLINE Profile Autoimmune Liver Disease 8 Ag (IgG) - 04049016124887

No Description
EUROIMMUN Medizinische Labordiagnostika AG
DL 1300-1601-8 G
In Commercial Distribution

  • 04049016124887 ()


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

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

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

ACCURUN® - 00816784020789

ACCURUN 1 Series 8100 Multi-Marker 3 x 5.0 mL
Lgc Clinical Diagnostics, Inc.
2000-0022
In Commercial Distribution

  • 00816784020789 ()
2000-0022

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

ACCURUN® - 00816784020772

ACCURUN 1 Series 5100 Multi-Marker 12 x 3.5 mL
Lgc Clinical Diagnostics, Inc.
2000-0017
In Commercial Distribution

  • 00816784020772 ()

  • Total Volume: 42 Milliliter
2000-0017

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

ACCURUN® - 00816784020765

ACCURUN 1 Series 5100 Multi-Marker Positive Control 3 x 5.0 mL
Lgc Clinical Diagnostics, Inc.
2000-0016
In Commercial Distribution

  • 00816784020765 ()

  • Total Volume: 15 Milliliter
2000-0016

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

ACCURUN® - 00816784020741

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

  • 00816784020741 ()


  • 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

ACCURUN® - 00816784020871

ACCURUN 1 Series 2700 Multi-Marker Positive Control 6 x 3.5 mL
Lgc Clinical Diagnostics, Inc.
2000-0005
In Commercial Distribution

  • 00816784020871 ()
2000-0005

  • Multiple blood-borne virus antigen/antibody 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

Clostridium Difficile Glutamate Dehydrogenase(GDH) and Toxin A/B Detection Kit ( - 06974849369236

No Description
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
20 tests/kit
In Commercial Distribution

  • 06974849369236 ()


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

Clostridium Difficile Glutamate Dehydrogenase(GDH) and Toxin A/B Detection Kit ( - 06974849369229

No Description
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
1 test/kit
In Commercial Distribution

  • 06974849369229 ()


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

Lumipulse Infectious Disease Controls - 04987270235584

No Description
FUJIREBIO INC.
235584
In Commercial Distribution

  • 04987270235584 ()

  • Number of bottles per kit = 8
  • Total mLs per bottle = 3/3/2.5


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

SpO2.COM® NRC-P12 Patient Cable - 00843997001380

No Description
MASIMO CORPORATION
1853
In Commercial Distribution

  • 00843997001380 ()


  • Electrical-only medical device connection cable, reusable

SpO2.COM® NRC-180 Patient Cable - 00843997001359

No Description
MASIMO CORPORATION
1810
In Commercial Distribution

  • 00843997001359 ()


  • Electrical-only medical device connection cable, reusable

CARDINAL HEALTH - 10888439398274

PEDI HEART B
Cardinal Health 200, LLC
SCV51PHLPX
In Commercial Distribution

  • 50888439398272 ()
  • 10888439398274 ()
SCV51PHLPX

  • Cardiothoracic surgical procedure kit, non-medicated, single-use

CARDINAL HEALTH - 10888439241297

PEDI HEART B
Cardinal Health 200, LLC
SCV51PHLP3
In Commercial Distribution

  • 50888439241295 ()
  • 10888439241297 ()
SCV51PHLP3

  • Cardiothoracic surgical procedure kit, non-medicated, single-use

CARDINAL HEALTH - 10888439218022

CYSTO TRAY B
Cardinal Health 200, LLC
SBAOCCTMSC
In Commercial Distribution

  • 50888439218020 ()
  • 10888439218022 ()
SBAOCCTMSC

  • Urological surgical procedure kit, non-medicated, single-use

ParaPost - D661L5950

Metal Wrench B
COLTENE/WHALEDENT INC
L595
In Commercial Distribution

  • D661L5950 ()


  • Root canal post, preformed

Shuttle Series B - Advanced - 00845699000463

Shuttle Series B
SIZEWISE RENTALS, L.L.C.
T1000-ADV
In Commercial Distribution

  • 00845699000463 ()


  • Mobile bariatric examination/treatment chair, electric

CARDINAL HEALTH - 10888439312249

CRANIOTOMY B PACK
Cardinal Health 200, LLC
SNE11CBLD8
In Commercial Distribution

  • 50888439312247 ()
  • 10888439312249 ()
SNE11CBLD8

  • Craniotomy kit

CARDINAL HEALTH - 10888439304329

PEDI HEART B
Cardinal Health 200, LLC
SCV51PHLP4
In Commercial Distribution

  • 50888439304327 ()
  • 10888439304329 ()
SCV51PHLP4

  • Cardiothoracic surgical procedure kit, non-medicated, single-use

CARDINAL HEALTH - 10888439315417

OPEN HEART B
Cardinal Health 200, LLC
SCV42NC522
In Commercial Distribution

  • 50888439315415 ()
  • 10888439315417 ()
SCV42NC522

  • Cardiothoracic surgical procedure kit, non-medicated, single-use

CARDINAL HEALTH - 10888439325584

A B TRAY
Cardinal Health 200, LLC
17B4553A
In Commercial Distribution

  • 50888439325582 ()
  • 10888439325584 ()
17B4553A

  • General surgical procedure kit, non-medicated, single-use

CARDINAL HEALTH - 10888439296716

CRANIOTOMY B PACK
Cardinal Health 200, LLC
SNE11CBLDJ
In Commercial Distribution

  • 50888439296714 ()
  • 10888439296716 ()
SNE11CBLDJ

  • Craniotomy kit

Waterpik Neo-Temp Temporary Cement "B" Syringe - D6860522101

"B" syringe refill
WATER PIK, INC.
052210-000
In Commercial Distribution

  • D6860522101 ()

  • Weight: 10 Gram
052210-000

  • Dental composite resin

Medline Industries, Inc. - 10889942946730

CRANE PACK B
MEDLINE INDUSTRIES, INC.
DYNJ59322
In Commercial Distribution

  • 10889942946730 ()
DYNJ59322

  • General surgical procedure kit, non-medicated, single-use

Medline Industries, Inc. - 10889942924417

HEART B PACK
MEDLINE INDUSTRIES, INC.
DYNJ24764M
In Commercial Distribution

  • 10889942924417 ()
DYNJ24764M

  • General surgical procedure kit, non-medicated, single-use

Medline Industries, Inc. - 10195327249533

CARDIO B PACK
MEDLINE INDUSTRIES, INC.
DYNJ36052O
In Commercial Distribution

  • 40195327249534 ()
  • 10195327249533 ()
DYNJ36052O

  • General surgical procedure kit, non-medicated, single-use

Medline Industries, Inc. - 10889942032105

OPEN HEART B
MEDLINE INDUSTRIES, INC.
DYNJ901826A
In Commercial Distribution

  • 10889942032105 ()
DYNJ901826A

  • General surgical procedure kit, non-medicated, reusable

Medline Industries, Inc. - 10195327268848

HEART B PACK-LF
MEDLINE INDUSTRIES, INC.
DYNJ53589F
In Commercial Distribution

  • 10195327268848 ()
DYNJ53589F

  • General surgical procedure kit, non-medicated, single-use

HU-FRIEDY - 10889950045876

MODIFIED CVTCA/B
HU-FRIEDY MFG. CO., LLC
CV6783K
Not in Commercial Distribution

  • 10889950045876 ()
CV6783K

  • Dental restoration carver, amalgam, reusable

Medline Industries, Inc. - 10195327276300

OPEN HEART B
MEDLINE INDUSTRIES, INC.
DYNJ906018C
In Commercial Distribution

  • 10195327276300 ()
DYNJ906018C

  • General surgical procedure kit, non-medicated, single-use

Medline Industries, Inc. - 10889942073832

HEART B PACK-LF
MEDLINE INDUSTRIES, INC.
DYNJ0550836J
In Commercial Distribution

  • 10889942073832 ()
  • 40889942073833 ()
DYNJ0550836J

  • General surgical procedure kit, non-medicated, single-use

Medline Industries, Inc. - 10889942118892

CABG PROCEDURE B
MEDLINE INDUSTRIES, INC.
DYNJ902587
In Commercial Distribution

  • 10889942118892 ()
DYNJ902587

  • General surgical procedure kit, non-medicated, reusable

Medline Industries, Inc. - 10889942529872

DR B PACK
MEDLINE INDUSTRIES, INC.
DYNJ38452B
In Commercial Distribution

  • 10889942529872 ()
DYNJ38452B

  • General surgical procedure kit, non-medicated, reusable

Medline Industries, Inc. - 10889942728626

OPEN HEART B
MEDLINE INDUSTRIES, INC.
DYNJ903739B
In Commercial Distribution

  • 10889942728626 ()
DYNJ903739B

  • General surgical procedure kit, non-medicated, single-use

Medline Industries, Inc. - 10195327058067

CV A & B
MEDLINE INDUSTRIES, INC.
DYNJ22215M
In Commercial Distribution

  • 10195327058067 ()
DYNJ22215M

  • General surgical procedure kit, non-medicated, single-use
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