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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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Tinto Mycobacterium tuberculosis RPab - B502BSB29930

Mycobacterium tuberculosis is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 7 ml
In Commercial Distribution

  • B502BSB29930 ()
BSB 2993

  • Mycobacterium tuberculosis immunoglobulin G (IgG) antibody IVD, reagent

Tinto Mycobacterium tuberculosis RPab - B502BSB29920

Mycobacterium tuberculosis is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 3 ml
In Commercial Distribution

  • B502BSB29920 ()
BSB 2992

  • Mycobacterium tuberculosis immunoglobulin G (IgG) antibody IVD, reagent

ACCURUN® Anti-SARS-CoV-2 Controls Kit Series 1000 - 00816784020963

ACCURUN® Anti-SARS-CoV-2 Controls Kit Series 1000
Lgc Clinical Diagnostics, Inc.
2015-0222
In Commercial Distribution

  • 00816784020963 ()


  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control

CERAMAX - 10603295012719

CERAMAX Ceramic Insert NEUTRAL 60mm OD 28mm ID
DEPUY ORTHOPAEDICS, INC.
1218-89-660
In Commercial Distribution

  • 10603295012719 ()
121889660

  • Ceramic acetabular liner

CERAMAX - 10603295012702

CERAMAX Ceramic Insert NEUTRAL 58mm OD 28mm ID
DEPUY ORTHOPAEDICS, INC.
1218-89-658
In Commercial Distribution

  • 10603295012702 ()
121889658

  • Ceramic acetabular liner

CERAMAX - 10603295012696

CERAMAX Ceramic Insert NEUTRAL 56mm OD 28mm ID
DEPUY ORTHOPAEDICS, INC.
1218-89-656
In Commercial Distribution

  • 10603295012696 ()
121889656

  • Ceramic acetabular liner

CERAMAX - 10603295012689

CERAMAX Ceramic Insert NEUTRAL 54mm OD 28mm ID
DEPUY ORTHOPAEDICS, INC.
1218-89-654
In Commercial Distribution

  • 10603295012689 ()
121889654

  • Ceramic acetabular liner

CERAMAX - 10603295012672

CERAMAX Ceramic Insert NEUTRAL 52mm OD 28mm ID
DEPUY ORTHOPAEDICS, INC.
1218-89-652
In Commercial Distribution

  • 10603295012672 ()
121889652

  • Ceramic acetabular liner

CERAMAX - 10603295012665

CERAMAX Ceramic Insert NEUTRAL 50mm OD 28mm ID
DEPUY ORTHOPAEDICS, INC.
1218-89-650
In Commercial Distribution

  • 10603295012665 ()
121889650

  • Ceramic acetabular liner

CERAMAX - 10603295012658

CERAMAX Ceramic Insert NEUTRAL 48mm OD 28mm ID
DEPUY ORTHOPAEDICS, INC.
1218-89-648
In Commercial Distribution

  • 10603295012658 ()
121889648

  • Ceramic acetabular liner

CERAMAX - 10603295012580

CERAMAX Ceramic Insert NEUTRAL 66mm OD 36mm ID
DEPUY ORTHOPAEDICS, INC.
1218-87-666
In Commercial Distribution

  • 10603295012580 ()
121887666

  • Ceramic acetabular liner

CERAMAX - 10603295012573

CERAMAX Ceramic Insert NEUTRAL 64mm OD 36mm ID
DEPUY ORTHOPAEDICS, INC.
1218-87-664
In Commercial Distribution

  • 10603295012573 ()
121887664

  • Ceramic acetabular liner

CERAMAX - 10603295012566

CERAMAX Ceramic Insert NEUTRAL 62mm OD 36mm ID
DEPUY ORTHOPAEDICS, INC.
1218-87-662
In Commercial Distribution

  • 10603295012566 ()
121887662

  • Ceramic acetabular liner

CERAMAX - 10603295012559

CERAMAX Ceramic Insert NEUTRAL 60mm OD 36mm ID
DEPUY ORTHOPAEDICS, INC.
1218-87-660
In Commercial Distribution

  • 10603295012559 ()
121887660

  • Ceramic acetabular liner

CERAMAX - 10603295012542

CERAMAX Ceramic Insert NEUTRAL 58mm OD 36mm ID
DEPUY ORTHOPAEDICS, INC.
1218-87-658
In Commercial Distribution

  • 10603295012542 ()
121887658

  • Ceramic acetabular liner

CERAMAX - 10603295012535

CERAMAX Ceramic Insert NEUTRAL 56mm OD 36mm ID
DEPUY ORTHOPAEDICS, INC.
1218-87-656
In Commercial Distribution

  • 10603295012535 ()
121887656

  • Ceramic acetabular liner

CERAMAX - 10603295012528

CERAMAX Ceramic Insert NEUTRAL 54mm OD 36mm ID
DEPUY ORTHOPAEDICS, INC.
1218-87-654
In Commercial Distribution

  • 10603295012528 ()
121887654

  • Ceramic acetabular liner

CERAMAX - 10603295012511

CERAMAX Ceramic Insert NEUTRAL 52mm OD 36mm ID
DEPUY ORTHOPAEDICS, INC.
1218-87-652
In Commercial Distribution

  • 10603295012511 ()
121887652

  • Ceramic acetabular liner

PreciControl Anti-SARS-CoV-2 - 07613336180167

No Description
Roche Diagnostics GmbH
09216928190
In Commercial Distribution

  • 07613336180167 ()
09216928190

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control

Respiratory Syncytial Virus Antigen Substrate, 12 wells, For IFA Test System - B110RS90120

No Description
Bion Enterprises, Ltd.
RS-9012
In Commercial Distribution

  • B110RS90120 ()
RS-9012

  • Respiratory syncytial virus (RSV) immunoglobulin G (IgG) antibody IVD, reagent

EBV Nuclear Antigen (EBNA) Substrate, 12 wells, For ACIF Test System - B110NA51120

No Description
Bion Enterprises, Ltd.
NA-5112
Not in Commercial Distribution

  • B110NA51120 ()
NA-5112

  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, reagent

Influenza B Virus Antigen Substrate, 12 wells, For IFA Test System - B110IB21120

No Description
Bion Enterprises, Ltd.
IB-2112
In Commercial Distribution

  • B110IB21120 ()
IB-2112

  • Influenza B virus immunoglobulin G (IgG) antibody IVD, reagent

Influenza A Virus Antigen Substrate, 12 wells, For IFA Test System - B110IA11120

No Description
Bion Enterprises, Ltd.
IA-1112
In Commercial Distribution

  • B110IA11120 ()
IA-1112

  • Influenza A virus immunoglobulin G (IgG) antibody IVD, reagent

Herpes Simplex IgG Control - B110HSG35200

No Description
Bion Enterprises, Ltd.
HSG-3520
In Commercial Distribution

  • B110HSG35200 ()
HSG-3520

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, control

DJO SURGICAL - 00888912087636

Ceramic Liner - Size 32
Encore Medical, L.P.
498-32-064
In Commercial Distribution

  • 00888912087636 ()


  • Ceramic acetabular liner

DJO SURGICAL - 00888912087629

Ceramic Liner - Size 32
Encore Medical, L.P.
498-32-060
In Commercial Distribution

  • 00888912087629 ()


  • Ceramic acetabular liner

DJO SURGICAL - 00888912087612

Ceramic Liner - Size 32
Encore Medical, L.P.
498-32-056
In Commercial Distribution

  • 00888912087612 ()


  • Ceramic acetabular liner

DJO SURGICAL - 00888912087599

Ceramic Liner - Size 32
Encore Medical, L.P.
498-32-052
In Commercial Distribution

  • 00888912087599 ()


  • Ceramic acetabular liner

DJO SURGICAL - 00888912087537

Ceramic Liner - Size 28
Encore Medical, L.P.
498-28-048
In Commercial Distribution

  • 00888912087537 ()


  • Ceramic acetabular liner

HYTEC Penicillium notatum - 00816879022377

No Description
HYCOR BIOMEDICAL LLC
M001
Not in Commercial Distribution

  • 00816879022377 ()
74383

  • Immunoglobulin G subclass (IgG subclass) IVD, reagent

HYTEC Cow Dander - 00816879022353

No Description
HYCOR BIOMEDICAL LLC
E004
Not in Commercial Distribution

  • 00816879022353 ()
74220

  • Immunoglobulin G subclass (IgG subclass) IVD, reagent

HYTEC Blackberry, Rubus fruitcosus - 00816879025972

No Description
HYCOR BIOMEDICAL LLC
F211
Not in Commercial Distribution

  • 00816879025972 ()
746040

  • Immunoglobulin G subclass (IgG subclass) IVD, reagent

Toxoplasma gondii RPab - B502BSB60480

Anti-Toxoplasma is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 1 ml
In Commercial Distribution

  • B502BSB60480 ()
BSB 6048

  • Toxoplasma gondii immunoglobulin A (IgA)/IgG/IgM antibody IVD, control

Toxoplasma gondii RPab - B502BSB60470

Anti-Toxoplasma is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 0.5 ml
In Commercial Distribution

  • B502BSB60470 ()
BSB 6047

  • Toxoplasma gondii immunoglobulin A (IgA)/IgG/IgM antibody IVD, control

Toxoplasma gondii RPab - B502BSB60460

Anti-Toxoplasma is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 0.1 ml
In Commercial Distribution

  • B502BSB60460 ()
BSB 6046

  • Toxoplasma gondii immunoglobulin A (IgA)/IgG/IgM antibody IVD, control

Tinto Toxoplasma gondii ,RPab - B502BSB60450

Tinto Toxoplasma gondii is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 15 ml
In Commercial Distribution

  • B502BSB60450 ()
BSB 6045

  • Toxoplasma gondii immunoglobulin A (IgA)/IgG/IgM antibody IVD, control

Tinto Toxoplasma gondii, RPab - B502BSB60440

Tinto Toxoplasma gondii is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 7 ml
In Commercial Distribution

  • B502BSB60440 ()
BSB 6044

  • Toxoplasma gondii immunoglobulin A (IgA)/IgG/IgM antibody IVD, control

Tinto Toxoplasma gondii RPab - B502BSB60430

Tinto Toxoplasma gondii is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 3 ml
In Commercial Distribution

  • B502BSB60430 ()
BSB 6043

  • Toxoplasma gondii immunoglobulin A (IgA)/IgG/IgM antibody IVD, control

Tinto Helicobacter pylori RPab - B502BSB56030

Helicobacter pylori antibody for immunohistochemistry is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 3 ml
In Commercial Distribution

  • B502BSB56030 ()
BSB 5603

  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, reagent

Helicobacter pylori RPab - B502BSB56080

H. pylori is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 1 ml
In Commercial Distribution

  • B502BSB56080 ()
BSB 5608

  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, reagent

Helicobacter pylori RPab - B502BSB56070

H. pylori is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 0.5 ml
In Commercial Distribution

  • B502BSB56070 ()
BSB 5607

  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, reagent

Helicobacter pylori RPab - B502BSB56060

Helicobacter pylori is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 0.1 ml
In Commercial Distribution

  • B502BSB56060 ()
BSB 5606

  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, reagent

Tinto Helicobacter pylori RPab - B502BSB56050

Helicobacter pylori antibody for immunohistochemistry is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 15 ml
In Commercial Distribution

  • B502BSB56050 ()
BSB 5605

  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, reagent

Tinto Helicobacter pylori RPab - B502BSB56040

Tinto Helicobacter pylori is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Prediluted, 7 ml
In Commercial Distribution

  • B502BSB56040 ()
BSB5604

  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, reagent

LiquidQC CoV-2 IgG Control - 00817238010035

CLINIQA Liquid QCTM CoV-2 IgG Control an un-assayed quality control material for SARS-CoV-2 IgG assays.
CLINIQA CORPORATION
91494
Not in Commercial Distribution

  • 00817238010035 ()


  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control

Drill Stopper for Long L11.5 1856 - 07290105157638

No Description
ADIN DENTAL IMPLANT SYSTEMS LTD
S1856L11.5
In Commercial Distribution

  • 07290105157638 ()


  • Borna disease virus immunoglobulin G (IgG) antibody IVD, reagent

Access SARS-CoV-2 IgG II QC - 15099590742768

The Access SARS-CoV-2 IgG II QC is intended for monitoring system performance of the Access SARS-CoV-2 IgG II assay using the Access Immunoassay Systems only. The Access SARS-CoV-2 IgG II QC are only for use under the Food and Drug Administration's Emergency Use Authorization.
Beckman Coulter, Inc.
C69059
In Commercial Distribution

  • 15099590742768 ()
C69059

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control

Access SARS-CoV-2 IgG QC - 15099590738662

The Access SARS-CoV-2 IgG QC is intended for monitoring system performance of the Access SARS-CoV-2 IgG assay. The Access SARS-CoV-2 IgG QC is for use on the Access Family of Immunoassay Systems only. The Access SARS-CoV-2 IgG QC are only for use under the Food and Drug Administration's Emergency Use Authorization.
Beckman Coulter, Inc.
C58964
In Commercial Distribution

  • 15099590738662 ()
C58964

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control

R3 ACETABULAR - 00885556281444

R3 32MM ID US CERAMIC FORTE ACET LINER 58MM
Smith & Nephew, Inc.
71334858
In Commercial Distribution

  • 00885556281444 ()
71334858

  • Ceramic acetabular liner

R3 ACETABULAR - 00885556281390

R3 32MM ID US CERAMIC FORTE ACET LINER 56MM
Smith & Nephew, Inc.
71334856
In Commercial Distribution

  • 00885556281390 ()
71334856

  • Ceramic acetabular liner
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