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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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SALIVABUSE - 00810042682658

ORAL-SKREEN, 3X Cutoff, 6x20mL
BIOCHEMICAL DIAGNOSTICS INC
20200109-6pk
In Commercial Distribution

  • 00810042682658 ()
20200109-6pk

  • Multiple drugs of abuse IVD, control

SALIVABUSE - 00810042682634

ORAL-SKREEN , Neg/3X POSITIVE KITBOX, 2x20mL
BIOCHEMICAL DIAGNOSTICS INC
702030
In Commercial Distribution

  • 00810042682634 ()
702030

  • Multiple drugs of abuse IVD, control

SALIVABUSE - 00810042682627

Oral Fluid, 3X Cutoff, 20mL
BIOCHEMICAL DIAGNOSTICS INC
20200109
In Commercial Distribution

  • 00810042682627 ()
20200109

  • Multiple drugs of abuse IVD, control

SALIVABUSE - 00810042682610

Oral Fluid, 2X Cutoff, 20mL
BIOCHEMICAL DIAGNOSTICS INC
20200108
In Commercial Distribution

  • 00810042682610 ()
20200108

  • Multiple drugs of abuse IVD, control

SALIVABUSE - 00810042682603

Oral Fluid, Cutoff +50%, 20mL
BIOCHEMICAL DIAGNOSTICS INC
20200107
In Commercial Distribution

  • 00810042682603 ()
20200107

  • Multiple drugs of abuse IVD, control

SALIVABUSE - 00810042682597

Oral Fluid, Cutoff -50%, 20mL
BIOCHEMICAL DIAGNOSTICS INC
20200103
In Commercial Distribution

  • 00810042682597 ()
20200103

  • Multiple drugs of abuse IVD, control

Para 12 Extend - 50844509000612

A Multi-Parameter Assayed Hematology Control for Instruments Offering a 3-Part Differential. Contains 1 vial of normal level.
STRECK, INC.
218752
In Commercial Distribution

  • 50844509000612 ()

  • Total Volume: 2.5 Milliliter
218752

  • Full blood count IVD, control

OPTIGEN® Allergen-Specific IgE Assay - US Environmental 36 (40ND) - 00813382012178

KIT, OPTIGEN US Environmental 36 (40ND)
Minaris Medical America, Inc.
85168
In Commercial Distribution

  • 00813382012178 ()
85168

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay

OPTIGEN® Allergen-Specific IgE Assay - US Food 30 (40ND) - 00813382012154

KIT, OPTIGEN US Food 30 (40ND)
Minaris Medical America, Inc.
85167
In Commercial Distribution

  • 00813382012154 ()
85167

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay

OPTIGEN® Allergen-Specific IgE Assay - US Food 25 (100 ND) - 00813382010440

KIT, OPTIGEN US Food 25
Minaris Medical America, Inc.
85066
In Commercial Distribution

  • 00813382010440 ()
85066

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
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