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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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DETECTABUSE - 00810042683921

SERIES V-H, Cutoff -25%, 20mL
BIOCHEMICAL DIAGNOSTICS INC
19555252
In Commercial Distribution

  • 00810042683921 ()
19555252

  • Multiple drugs of abuse IVD, control

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 - 00810042682597

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

  • 00810042682597 ()
20200103

  • Multiple drugs of abuse IVD, control

HQ-Chex - 20844509001694

A whole blood glucose and hemoglobin control designed to evaluate the accuracy and precision of HemoCue® analyzers. Contains 6 vials of level 3.
STRECK, INC.
232755
In Commercial Distribution

  • 20844509001694 ()

  • Total Volume: 2.5 Milliliter
232755

  • Glucose/haemoglobin (Hb) IVD, control

HQ-Chex - 20844509001687

A whole blood glucose and hemoglobin control designed to evaluate the accuracy and precision of HemoCue® analyzers. Contains 6 vials of level 2.
STRECK, INC.
232754
In Commercial Distribution

  • 20844509001687 ()

  • Total Volume: 2.5 Milliliter
232754

  • Glucose/haemoglobin (Hb) IVD, control

HQ-Chex - 20844509001670

A whole blood glucose and hemoglobin control designed to evaluate the accuracy and precision of HemoCue® analyzers. Contains 6 vials of level 1.
STRECK, INC.
232753
In Commercial Distribution

  • 20844509001670 ()

  • Total Volume: 2.5 Milliliter
232753

  • Glucose/haemoglobin (Hb) IVD, control

ESR-Chex - 20844509001618

A two-level hematology control used to monitor erythrocyte sedimentation rates. Contains 4 vials of level 2.
STRECK, INC.
214024
In Commercial Distribution

  • 20844509001618 ()

  • Total Volume: 9.0 Milliliter
214024

  • Erythrocyte sedimentation rate (ESR) IVD, control

ESR-Chex - 20844509001601

A two-level hematology control used to monitor erythrocyte sedimentation rates. Contains 4 vials of level 1.
STRECK, INC.
214014
In Commercial Distribution

  • 20844509001601 ()

  • Total Volume: 9.0 Milliliter
214014

  • Erythrocyte sedimentation rate (ESR) IVD, control
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