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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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ACS - 00191072071545

CYSTO PK, STRL G/ G
AMERICAN CONTRACT SYSTEMS, INC.
FHCP01K
In Commercial Distribution

  • 00191072071545 ()


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

ACS - 00191072091468

CYSTO PK, STRL G/ G
AMERICAN CONTRACT SYSTEMS, INC.
FHCP01N
In Commercial Distribution

  • 00191072091468 ()


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

ACS - 00191072199287

CYSTO PK, STRL G/ G
AMERICAN CONTRACT SYSTEMS, INC.
FHCP01R
In Commercial Distribution

  • 00191072199287 ()


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

ACS - 00191072184757

CYSTO PK, STRL G/ G
AMERICAN CONTRACT SYSTEMS, INC.
FHCP01Q
In Commercial Distribution

  • 00191072184757 ()


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

ACS - 00191072108289

CYSTO PK, STRL G/ G
AMERICAN CONTRACT SYSTEMS, INC.
FHCP01O
In Commercial Distribution

  • 00191072108289 ()


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

Trinity Biotech - 05391516747820

Legionella IFA Test System,(Legionella species), 180 Tests
MARDX DIAGNOSTICS, INC.
30-7980
In Commercial Distribution

  • 05391516747820 ()
30-7980

  • Legionella longbeachae immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay

Trinity Biotech - 05391516747622

B. burgdorferi WB IgG Serum Band Locator, 250µL
MARDX DIAGNOSTICS, INC.
40-2023L
In Commercial Distribution

  • 05391516747622 ()
40-2023L

  • Legionella pneumophila immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay

Trinity Biotech - 05391516747202

Captia™ Legionella pneumophila IgG/IgM
CLARK LABORATORIES, INC.
2346980
In Commercial Distribution

  • 05391516747202 ()

  • 96 Tests
2346980

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

Kallestad - 00847865001496

MONOFLUO Legionella pneumophila IFA Test Kit
Bio-RAD Laboratories, Inc.
32514
In Commercial Distribution

  • 00847865001496 ()

  • 24 Tests
32514

  • Legionella pneumophila immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay

IMMCO DIAGNOSTICS - 00845714003066

IgA/IgG FITC Conjugate w/EB
IMMCO DIAGNOSTICS, INC.
2113-15
In Commercial Distribution

  • 00845714003066 ()

  • 15 ml
2113-15

  • Human immunoglobulin A (IgA)/IgG/IgM animal conjugate antibody reagent IVD
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