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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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Bio-Rad Laboratories, Inc. - 00847865011273

Anti-Borrelia (Lyme) EIA , Substrate Concentrate
Bio-RAD Laboratories, Inc.
25276
In Commercial Distribution

  • 00847865011273 ()

  • Total Volume: 1.5 Milliliter
25276

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)

Bio-Rad Laboratories, Inc. - 00847865011266

Anti-Borrelia (Lyme) EIA, Substrate Buffer
Bio-RAD Laboratories, Inc.
25275
In Commercial Distribution

  • 00847865011266 ()

  • Total Volume: 25 Milliliter
25275

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)

Bio-Rad Laboratories, Inc. - 00847865011259

Anti-Borrelia (Lyme) EIA, Wash Buffer Concentrate [20X]
Bio-RAD Laboratories, Inc.
25273
In Commercial Distribution

  • 00847865011259 ()

  • Total Volume: 50 Milliliter
25273

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)

Trinity Biotech - 05391516747547

B. burgdorferi Wash Buffer (10x)
CLARK LABORATORIES, INC.
40-1013
In Commercial Distribution

  • 05391516747547 ()

  • Total Volume: 100 Milliliter
40-1013

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)

Trinity Biotech - 05391516747721

10x Wash Solution, 100 mL
MARDX DIAGNOSTICS, INC.
40-1013
In Commercial Distribution

  • 05391516747721 ()
40-1013

  • Bordetella pertussis immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, enzyme immunoassay (EIA)
  • Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
  • Helicobacter pylori immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

ACS - 00191072108289

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

  • 00191072108289 ()


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

ACS - 00191072003430

CYSTO PK, STRL G/ G
AMERICAN CONTRACT SYSTEMS, INC.
FHCP01I
In Commercial Distribution

  • 00191072003430 ()


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

ACS - 00191072234322

CYSTO PK| STRL G/ G
AMERICAN CONTRACT SYSTEMS, INC.
FHCP01S
In Commercial Distribution

  • 00191072234322 ()


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

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 - 00191072061553

CYSTO PK, STRL G/ G
AMERICAN CONTRACT SYSTEMS, INC.
FHCP01J
In Commercial Distribution

  • 00191072061553 ()


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