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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 - 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 - 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

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

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

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

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® - 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

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

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

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

NA - 04260498580002

No Description
TEC COM GmbH, Gesellschaft für Technik, Technologie und Vermarktung
TECOTHERM NEO
In Commercial Distribution

  • 04260498580002 ()


  • External circulating-fluid core temperature regulation system control unit, heating/cooling

Medline Industries, Inc. - 10195327697006

HEART B PACK-LF
MEDLINE INDUSTRIES, INC.
DYNJ53589G
In Commercial Distribution

  • 10195327697006 ()
DYNJ53589G

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

Medline Industries, Inc. - 10195327695446

LAVH PART B
MEDLINE INDUSTRIES, INC.
DYNJV0312D
In Commercial Distribution

  • 40195327695447 ()
  • 10195327695446 ()
DYNJV0312D

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

CARDINAL HEALTH - 10195594038069

O B PACK
Cardinal Health 200, LLC
SMA34DLWML
In Commercial Distribution

  • 50195594038067 ()
  • 10195594038069 ()
SMA34DLWML

  • Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use

Medline Industries, Inc. - 10195327660666

O B PACK
MEDLINE INDUSTRIES, INC.
DYNJ85322A
In Commercial Distribution

  • 40195327660667 ()
  • 10195327660666 ()
DYNJ85322A

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

Medline Industries, Inc. - 10195327677527

OPEN HEART B
MEDLINE INDUSTRIES, INC.
DYNJ903739K
In Commercial Distribution

  • 10195327677527 ()
DYNJ903739K

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

Medline Industries, Inc. - 10195327609405

HEART A&B
MEDLINE INDUSTRIES, INC.
DYNJ910153
In Commercial Distribution

  • 10195327609405 ()
DYNJ910153

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

HU-FRIEDY - 10889950008260

#B Cogswell Elevator
HU-FRIEDY MFG. CO., LLC
EB
In Commercial Distribution

  • 10889950008260 ()
EB

  • Dental elevator, tooth/root

Medline Industries, Inc. - 10889942870578

TVC B PACK
MEDLINE INDUSTRIES, INC.
DYNJ58586
In Commercial Distribution

  • 10889942870578 ()
DYNJ58586

  • 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. - 10889942207671

CV A & B
MEDLINE INDUSTRIES, INC.
DYNJ22215K
In Commercial Distribution

  • 10889942207671 ()
DYNJ22215K

  • General surgical procedure kit, non-medicated, reusable

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
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