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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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HEp-2000® Fluorescent ANA-Ro Test System - M7490202321

ANA Nucleolar Positive Control - 2 x 1 ml
IMMUNO CONCEPTS INC
2023 (2)
In Commercial Distribution

  • M7490202321 ()
2023 (2)

  • Multiple antinuclear antibody (ANA) screening IVD, control

HEp-2000® Fluorescent ANA-Ro Test System - M7490202221

ANA Speckled Positive Control - 2 x 1 ml
IMMUNO CONCEPTS INC
2022 (2)
In Commercial Distribution

  • M7490202221 ()
2022 (2)

  • Multiple antinuclear antibody (ANA) screening IVD, control

Tryptic Soy Broth 15g/L 2L in 20L bag - 05407010127195

No Description
Lonza Verviers
BE26-279P20/2
In Commercial Distribution

  • 05407010127195 ()
BE26-279P20/2

  • Differential/selective broth culture medium IVD

ANCA Test System - M7491003121

ANCA Negative Control - 2 x 1 ml.
IMMUNO CONCEPTS INC
10031 (2)
In Commercial Distribution

  • M7491003121 ()
10031 (2)

  • Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, control

ANCA Test System - M749100261221

cANCA Titratable Control - PR3 2 x 0.25ml
IMMUNO CONCEPTS INC
10026-12 (2)
In Commercial Distribution

  • M749100261221 ()
10026-12 (2)

  • Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, control

ANCA Test System - M749100261121

pANCA Titratable Control - MPO - 2 x 0.25ml
IMMUNO CONCEPTS INC
10026-11 (2)
In Commercial Distribution

  • M749100261121 ()
10026-11 (2)

  • Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, control

ANCA Test System - M749100211221

cANCA Positive Control - 2 x 1 ml.
IMMUNO CONCEPTS INC
10021-12 (2)
In Commercial Distribution

  • M749100211221 ()
10021-12 (2)

  • Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, control

ANCA Test System - M749100211121

pANCA Positive Control - 2 x 1 ml.
IMMUNO CONCEPTS INC
10021-11 (2)
In Commercial Distribution

  • M749100211121 ()
10021-11 (2)

  • Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, control

CEKA & PRECI-LINE ATTACHMENTS - 14260576941838

M3 IMPRESSION TOOL BASE RING 2 PCS
Alphadent NV
H 2
In Commercial Distribution

  • 04260576941831 ()
  • 14260576941838 ()

  • Outer Diameter: 3 Millimeter
  • M3 threading
H 2

  • Dental precision attachment fitting/adjustment tool

Bausch + Lomb - 00757770420674

TRAY STERILIZATION HOLDS 30
Bausch & Lomb Incorporated
E7416 2
In Commercial Distribution

  • 00757770420674 ()
E7416 2

  • Instrument tray, reusable
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