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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 CHIV - 00630414600390

CHIV - Atellica IM - RGT - 100T
Siemens Healthcare Diagnostics Inc.
10995459
In Commercial Distribution

  • 00630414600390 ()
10995459

  • HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay

Atellica IM APW1 - 00630414600383

Ancillary Probe Wash (APW1) Atellica IM - CONS 2x25 mL
Siemens Healthcare Diagnostics Inc.
10995458
In Commercial Distribution

  • 00630414600383 ()
  • 00630414007281 ()
10995458

  • Buffered wash solution IVD

Atellica IM VitD QC - 00630414600376

Vitamin D total 25(OH) (VitD) QC Kit Atellica IM - CLT 2 x 3 x 2.0mL
Siemens Healthcare Diagnostics Inc.
10995724
In Commercial Distribution

  • 00630414600376 ()
10995724

  • Multiple form 25-hydroxy Vitamin D IVD, control

Atellica IM VitD MCM - 00630414600369

Vitamin D total 25 (OH) (VitD) Atellica IM Master Curve Material Kit 5 x 2 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995723
In Commercial Distribution

  • 00630414600369 ()
10995723

  • Multiple form 25-hydroxy Vitamin D IVD, control

Atellica IM VitD DIL - 00630414600345

Vitamin D total 25 (OH) (VitD) Diluent Atellica IM CONS (2PK) 2 x 5mL
Siemens Healthcare Diagnostics Inc.
10995721
In Commercial Distribution

  • 00630414600345 ()
  • 00630414007946 ()
10995721

  • Buffered sample diluent IVD

Atellica™ IM VitD - 00630414600338

Vitamin D total 25(OH) (VitD) - Atellica IM - RGT - 500T
Siemens Healthcare Diagnostics Inc.
10995720
In Commercial Distribution

  • 00630414600338 ()
10995720

  • Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay

Atellica™ IM VitD - 00630414600321

Vitamin D total 25(OH) (VitD) - Atellica IM - RGT - 100T
Siemens Healthcare Diagnostics Inc.
10995719
In Commercial Distribution

  • 00630414600321 ()
10995719

  • Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay

Atellica IM VB12 DTT/REL - 00630414600314

Vitamin B12 (VB12) DTT/REL Atellica IM - CONS
Siemens Healthcare Diagnostics Inc.
10995718
In Commercial Distribution

  • 00630414600314 ()
10995718

  • Vitamin B12 IVD, reagent

Atellica IM VB12 MCM - 00630414600307

Vitamin B12 (VB12) Atellica IM - Master Curve Material Kit 7 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995717
In Commercial Distribution

  • 00630414600307 ()
10995717

  • Vitamin B12 IVD, control

Atellica IM VB12 DIL - 00630414600291

Vitamin B12 (VB12) Diluent Atellica IM - CONS (2PK) 2 x 5mL
Siemens Healthcare Diagnostics Inc.
10995716
In Commercial Distribution

  • 00630414600291 ()
  • 00630414007908 ()
10995716

  • Buffered sample diluent IVD
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