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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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Atellica IM Herpes-1 IgG Quality Control - 00842768022791

Herpes-1 IgG (HSV1) Atellica IM - Quality Control
Siemens Healthcare Diagnostics Inc.
10733032
In Commercial Distribution

  • 00842768022791 ()
10733032

  • Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, control

Atellica IM aHBe2 QC - 00842768022685

Anti-HBe2 (aHBe2) – Atellica IM – QC Kit
Siemens Healthcare Diagnostics Inc.
10733022
In Commercial Distribution

  • 00842768022685 ()
10733022

  • Hepatitis B virus e-antigen total antibody IVD, control

Atellica IM AMH MCM Set - 00842768022395

AMH – Atellica IM - Master Curve Material Kit 4 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10998431
In Commercial Distribution

  • 00842768022395 ()
10998431

  • Anti-Mullerian hormone (AMH) IVD, control

Dimension® Flex® reagent cartridge IRON - 00842768020414

Iron Flex® reagent cartridge, 240 tests
Siemens Healthcare Diagnostics Inc.
10444945
In Commercial Distribution

  • 00842768020414 ()
  • 00630414004327 ()
DF85

  • Iron IVD, kit, spectrophotometry

N Latex CDT Kit - 00842768018534

Quantitative determination of carbohydrate-deficient transferrin (CDT) in human serum on BN II and BN ProSpec® Systems
Siemens Healthcare Diagnostics Products GmbH
10445997
In Commercial Distribution

  • 00842768018534 ()
OPCS05

  • Transferrin/transferrin isoform IVD, kit, nephelometry/turbidimetry

Dimension Vista® UDAT CON (-) - 00842768016479

Drugs of Abuse Negative Control, 6x2.5mL
Siemens Healthcare Diagnostics Inc.
10445199
In Commercial Distribution

  • 00842768016479 ()
  • 00630414005294 ()
KC516

  • Multiple drugs of abuse IVD, control

Dimension Vista® UDAT CON (+) - 00842768016462

Drugs of Abuse Positive Control, 6x2.5mL
Siemens Healthcare Diagnostics Inc.
10445198
In Commercial Distribution

  • 00842768016462 ()
  • 00630414005287 ()
KC515

  • Multiple drugs of abuse IVD, control

Dimension Vista® Sample Proble Cleaner 7 - 00842768016356

Sample Probe Cleaner, 2x2.4 L
Siemens Healthcare Diagnostics Inc.
10445209
In Commercial Distribution

  • 00842768016356 ()
  • 00630414005386 ()
KS807

  • Wash/cleaning solution IVD, automated/semi-automated system

Dimension Vista® Reagent Probe Cleaner 6 - 00842768016349

Reagent Probe Cleaner, 2x2.4 L
Siemens Healthcare Diagnostics Inc.
10445208
In Commercial Distribution

  • 00842768016349 ()
  • 00630414005379 ()
KS806

  • Wash/cleaning solution IVD, automated/semi-automated system

Dimension Vista® Cuvette Wash Solution 5 - 00842768016332

Cuvette wash solution, 2 x 2.4 L
Siemens Healthcare Diagnostics Inc.
10445207
In Commercial Distribution

  • 00842768016332 ()
  • 00630414005362 ()
KS805

  • Wash/cleaning solution IVD, automated/semi-automated system
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