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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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Trinity Biotech - 05391516747882

B. pertussis WB Negative Control, 250 µL
MARDX DIAGNOSTICS, INC.
40-6111
In Commercial Distribution

  • 05391516747882 ()
40-6111

  • Bordetella pertussis total antibody IVD, control

Trinity Biotech - 05391516747875

B. pertussis WB Positive IgG Control, 250 µL
MARDX DIAGNOSTICS, INC.
40-6025
In Commercial Distribution

  • 05391516747875 ()
40-6025

  • Bordetella pertussis total antibody IVD, control

Trinity Biotech - 05391516747868

Alkaline Phosphatase Conjugate, Anti-Human IgG (Goat), 9 mL
MARDX DIAGNOSTICS, INC.
40-6055G
In Commercial Distribution

  • 05391516747868 ()
40-6055G

  • Bordetella pertussis total antibody IVD, reagent

Bordetella pertussis ViraStripe IgG Test Kit - EVIRBPSGOK1

Immunoassay for the detection of IgG antibodies against Bordetella pertussis in human serum.
Viramed Biotech AG
V-BPSGOK
In Commercial Distribution

  • EVIRBPSGOK1 ()

  • 50 tests
V-BPSGOK

  • Bordetella pertussis total antibody IVD, kit, immunoblot

Bordetella pertussis ViraStripe IgG Deca Kit - EVIRBPSGDK1

Immunoassay for the detection of IgG antibodies against Bordetella pertussis in human serum.
Viramed Biotech AG
V-BPSGDK
In Commercial Distribution

  • EVIRBPSGDK1 ()

  • 500 tests
V-BPSGDK

  • Bordetella pertussis total antibody IVD, kit, immunoblot

Bordetella pertussis ViraStripe IgA Test Kit - EVIRBPSAOK1

Immunoassay for the detection of IgA antibodies against Bordetella pertussis in human serum.
Viramed Biotech AG
V-BPSAOK
In Commercial Distribution

  • EVIRBPSAOK1 ()

  • 50 tests
V-BPSAOK

  • Bordetella pertussis total antibody IVD, kit, immunoblot

Bordetella pertussis ViraStripe IgA Deca Kit - EVIRBPSADK1

Immunoassay for the detection of IgA antibodies against Bordetella pertussis in human serum.
Viramed Biotech AG
V-BPSADK
In Commercial Distribution

  • EVIRBPSADK1 ()

  • 500 tests
V-BPSADK

  • Bordetella pertussis total antibody IVD, kit, immunoblot

Anti-Bordetella pertussis ELISA (IgM) - 04049016096047

No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2050-9601 M
Not in Commercial Distribution

  • 04049016096047 ()


  • Bordetella pertussis immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Anti-Bordetella pertussis toxin ELISA (IgG) - 04049016085508

No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2050-9601 G
Not in Commercial Distribution

  • 04049016085508 ()


  • Bordetella pertussis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

EUROLINE Bordetella pertussis (IgG) - 04049016085478

No Description
EUROIMMUN Medizinische Labordiagnostika AG
DN 2050-24001 G
In Commercial Distribution

  • 04049016085478 ()


  • Bordetella pertussis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

EUROLINE Bordetella pertussis (IgA) - 04049016085461

No Description
EUROIMMUN Medizinische Labordiagnostika AG
DN 2050-24001 A
Not in Commercial Distribution

  • 04049016085461 ()


  • Bordetella pertussis immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)

EUROLINE Bordetella pertussis (IgG) - 04049016085447

No Description
EUROIMMUN Medizinische Labordiagnostika AG
DN 2050-1601 G
In Commercial Distribution

  • 04049016085447 ()


  • Bordetella pertussis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

EUROLINE Bordetella pertussis (IgA) - 04049016085430

No Description
EUROIMMUN Medizinische Labordiagnostika AG
DN 2050-1601 A
Not in Commercial Distribution

  • 04049016085430 ()


  • Bordetella pertussis immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)

Anti-Bordetella pertussis toxin ELISA (IgA) - 04049016085492

No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2050-9601 A
Not in Commercial Distribution

  • 04049016085492 ()


  • Bordetella pertussis immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)

Bordetella pertussis Toxin (PT) IgG ELISA - 00404847461336

The Bordetella pertussis Toxin, PT, IgG ELISA is intended for the quantitative determination of IgG class antibodies against B. pertussis toxin, PT, in human serum or plasma, -citrate, heparin.
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-6133
Not in Commercial Distribution

  • 00404847461336 ()
EIA-6133

  • Bordetella pertussis immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, enzyme immunoassay (EIA)

Bordetella pertussis IgG ELISA - 00404847434507

The DRG Bordetella pertussis IgG Enzyme Immunoassay Kit provides materials for the qualitative and semi-quantitative determination of IgG-class antibodies to Bordetella pertussis and Bordetella pertussis toxin in serum and plasma (EDTA-, heparin- or citrate plasma). This assay is intended for in vitro diagnostic use only.
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-3450
Not in Commercial Distribution

  • 00404847434507 ()
EIA-3450

  • Bordetella pertussis immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, enzyme immunoassay (EIA)

Bordetella pertussis Toxin (PT) IgG ELISA - 04048474061338

The Bordetella pertussis Toxin, PT, IgG ELISA is intended for the quantitative determination of IgG class antibodies against B. pertussis toxin, PT, in human serum or plasma, -citrate, heparin.
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-6133
Not in Commercial Distribution

  • 04048474061338 ()
EIA-6133

  • Bordetella pertussis immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, enzyme immunoassay (EIA)

Bordetella pertussis IgG ELISA - 04048474034509

The DRG Bordetella pertussis IgG Enzyme Immunoassay Kit provides materials for the qualitative and semi-quantitative determination of IgG-class antibodies to Bordetella pertussis and Bordetella pertussis toxin in serum and plasma (EDTA-, heparin- or citrate plasma).
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-3450
In Commercial Distribution

  • 04048474034509 ()
EIA-3450

  • Bordetella pertussis immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, enzyme immunoassay (EIA)

Bordetella pertussis IgG ELISA - 00840239034502

The DRG Bordetella pertussis IgG Enzyme Immunoassay Kit provides materials for the qualitative and semi-quantitative determination of IgG-class antibodies to Bordetella pertussis and Bordetella pertussis toxin in serum and plasma (EDTA-, heparin- or citrate plasma)
DRG International Inc
EIA-3450
In Commercial Distribution

  • 00840239034502 ()
EIA-3450

  • Bordetella pertussis immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, enzyme immunoassay (EIA)

Bordetella pertussis Toxin (PT) IgG ELISA - 00840239061331

The Bordetella pertussis Toxin, PT, IgG ELISA is intended for the quantitative determination of IgG class antibodies against B. pertussis toxin, PT, in human serum or plasma, -citrate, heparin.
DRG International Inc
EIA-6133
Not in Commercial Distribution

  • 00840239061331 ()
EIA-6133

  • Bordetella pertussis immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, enzyme immunoassay (EIA)

Bordetella pertussis IgG ELISA - B24220BPGHUE010

The Bordetella pertussis / toxin IgG Enzyme Immunoassay Kit provides materials for the qualitative and semiquantitative determination of IgG-class antibodies to Bordetella pertussis and Bordetella pertussis toxin in serum. This assay is intended for in vitro diagnostic use.
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
20-BPGHU-E01
In Commercial Distribution

  • B24220BPGHUE010 ()
20-BPGHU-E01

  • Bordetella pertussis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

NAMIC - 10193489087260

MTO 4 VALVE W/PROTECTION STATION COM
MEDLINE INDUSTRIES, INC.
60031052
In Commercial Distribution

  • 30193489087264 ()
  • 10193489087260 ()
60031052

  • Angiography kit

NAMIC - 10193489075120

MTO PICC/ANGIO SYRINGE KIT BOULDER COM
MEDLINE INDUSTRIES, INC.
650305410
In Commercial Distribution

  • 10193489075120 ()
650305410

  • Angiography kit

NAMIC - 10193489042467

MTO LEFT HEART KIT CENTRAL MICHIGAN COM
MEDLINE INDUSTRIES, INC.
60033151
In Commercial Distribution

  • 20193489042464 ()
  • 10193489042467 ()
60033151

  • Angiography kit

NAMIC - 10193489041927

MTO SINGLE MONING KIT BOULDER COM HOSP
MEDLINE INDUSTRIES, INC.
60030544
In Commercial Distribution

  • 20193489041924 ()
  • 10193489041927 ()
60030544

  • Angiography kit

NAMIC - 10193489060232

DBD-MTO ANGIO KIT COM HOSP ANDERSON PG
MEDLINE INDUSTRIES, INC.
65031863
In Commercial Distribution

  • 10193489060232 ()
65031863

  • Angiography kit

NORDENT MANUFACTURING INC - 00840018646902

COM PLACM INST DE #4T DILLYT DL-R
NORDENT MANUFACTURING INC
REPFI62T
In Commercial Distribution

  • 00840018646902 ()


  • Margin finishing dental file/rasp, reusable

NORDENT MANUFACTURING INC - 00840018637696

COM PLACM INST DE LR TIN DL-R
NORDENT MANUFACTURING INC
REPFILRT
In Commercial Distribution

  • 00840018637696 ()


  • Margin finishing dental file/rasp, reusable

NORDENT MANUFACTURING INC - 00840018637658

COM PLACM INST DE #7 TIN DL-R
NORDENT MANUFACTURING INC
REPFI7T
In Commercial Distribution

  • 00840018637658 ()


  • Margin finishing dental file/rasp, reusable

NORDENT MANUFACTURING INC - 00840018637627

COM PLACM INSDE #20 TIN 092 DL
NORDENT MANUFACTURING INC
REPFI72T
In Commercial Distribution

  • 00840018637627 ()


  • Margin finishing dental file/rasp, reusable

NORDENT MANUFACTURING INC - 00840018636750

COM PLACM INST DE #5 TIN DL-R
NORDENT MANUFACTURING INC
REPFI5T
In Commercial Distribution

  • 00840018636750 ()


  • Margin finishing dental file/rasp, reusable

NORDENT MANUFACTURING INC - 00840018636620

COM PLACM INST #3 TIN DL-R HDL
NORDENT MANUFACTURING INC
REPFI3T
In Commercial Distribution

  • 00840018636620 ()


  • Margin finishing dental file/rasp, reusable

NORDENT MANUFACTURING INC - 00840018635173

COM PLACM INST DE WOODSN #3 ST
NORDENT MANUFACTURING INC
PFIW3
In Commercial Distribution

  • 00840018635173 ()


  • Margin finishing dental file/rasp, reusable

NORDENT MANUFACTURING INC - 00840018635166

COM PLACM INST DE WOODSN #2 ST
NORDENT MANUFACTURING INC
PFIW2
In Commercial Distribution

  • 00840018635166 ()


  • Margin finishing dental file/rasp, reusable

NORDENT MANUFACTURING INC - 00840018635159

COM PLACM INST DE WOODSN #1 ST
NORDENT MANUFACTURING INC
PFIW1
In Commercial Distribution

  • 00840018635159 ()


  • Margin finishing dental file/rasp, reusable

NORDENT MANUFACTURING INC - 00840018635135

COM PLACM INST DE CRVD LR STD
NORDENT MANUFACTURING INC
PFILR
In Commercial Distribution

  • 00840018635135 ()


  • Margin finishing dental file/rasp, reusable

NORDENT MANUFACTURING INC. - 00840018635104

COM PLACM INST DE GREGG #4-5 S
NORDENT MANUFACTURING INC
PFIG4-5
In Commercial Distribution

  • 00840018635104 ()


  • Margin finishing dental file/rasp, reusable

NORDENT MANUFACTURING INC - 00840018635012

COM PLACM INST DE #8A STD HDL
NORDENT MANUFACTURING INC
PFI8A
In Commercial Distribution

  • 00840018635012 ()


  • Margin finishing dental file/rasp, reusable

NORDENT MANUFACTURING INC - 00840018634985

COM PLACM INST CP2 #6 STD HDL
NORDENT MANUFACTURING INC
PFI6
In Commercial Distribution

  • 00840018634985 ()


  • Margin finishing dental file/rasp, reusable

NORDENT MANUFACTURING INC - 00840018634978

COM PLACM INST DE #5 STD HDL
NORDENT MANUFACTURING INC
PFI5
In Commercial Distribution

  • 00840018634978 ()


  • Margin finishing dental file/rasp, reusable

NORDENT MANUFACTURING INC - 00840018634930

COM PLACM INST DE #4 STD HDL
NORDENT MANUFACTURING INC
PFI4
In Commercial Distribution

  • 00840018634930 ()


  • Margin finishing dental file/rasp, reusable

NORDENT MANUFACTURING INC - 00840018634893

COM PLACM INST DE #3 STD HDL
NORDENT MANUFACTURING INC
PFI3
In Commercial Distribution

  • 00840018634893 ()


  • Margin finishing dental file/rasp, reusable

NORDENT MANUFACTURING INC - 00840018634862

COM PLACM INST DE #20 STD HNDL
NORDENT MANUFACTURING INC
PFI20
In Commercial Distribution

  • 00840018634862 ()


  • Margin finishing dental file/rasp, reusable

NORDENT MANUFACTURING INC - 00840018634855

COM PLACM INST DE #2 STD HDL
NORDENT MANUFACTURING INC
PFI2
In Commercial Distribution

  • 00840018634855 ()


  • Margin finishing dental file/rasp, reusable

NORDENT MANUFACTURING INC - 00840018634794

COM PLACM INST DE #1 STD HDL
NORDENT MANUFACTURING INC
PFI1
In Commercial Distribution

  • 00840018634794 ()


  • Margin finishing dental file/rasp, reusable

NORDENT MANUFACTURING INC - 00840018636873

COM PLACMENT INST DE, LR TiN D
NORDENT MANUFACTURING INC
REPFILRT-H
In Commercial Distribution

  • 00840018636873 ()


  • Margin finishing dental file/rasp, reusable

NORDENT MANUFACTURING INC - 00840018636668

COM PLACM INST DE #4 TIN DL-R
NORDENT MANUFACTURING INC
REPFI4T
In Commercial Distribution

  • 00840018636668 ()


  • Margin finishing dental file/rasp, reusable

NORDENT MANUFACTURING INC - 00840018636590

COM PLACM INST DE #39-20 TIN D
NORDENT MANUFACTURING INC
REPFI39T-20T
In Commercial Distribution

  • 00840018636590 ()


  • Margin finishing dental file/rasp, reusable

NORDENT MANUFACTURING INC - 00840018636521

COM PLACE DE, #32 TIN #28 TIN
NORDENT MANUFACTURING INC
REPFI32AT-28BT
In Commercial Distribution

  • 00840018636521 ()


  • Margin finishing dental file/rasp, reusable

NORDENT MANUFACTURING INC - 00840018636484

COM PLACM INST DE #2 TIN DL-R
NORDENT MANUFACTURING INC
REPFI2T
In Commercial Distribution

  • 00840018636484 ()


  • Margin finishing dental file/rasp, reusable
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