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 Class Implantable

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Insulin (IRI) Diluent Bottle Atellica IM - CONS) 1 x 10mL
Siemens Healthcare Diagnostics Inc.
10995631
In Commercial Distribution

  • 00630414600475 ()
10995631

  • Buffered sample diluent IVD
Insulin (IRI) Diluent Atellica IM - CONS (2PK) 2 x 10mL
Siemens Healthcare Diagnostics Inc.
10995630
In Commercial Distribution

  • 00630414600468 ()
  • 00630414007953 ()
10995630

  • Buffered sample diluent IVD
Insulin (IRI) Calibrator Atellica IM - CAL (2PK) 2 x 2 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995629
In Commercial Distribution

  • 00630414600451 ()
  • 00842768027406 ()
10995629

  • Insulin IVD, calibrator
Insulin (IRI) Atellica IM - RGT 100T
Siemens Healthcare Diagnostics Inc.
10995628
In Commercial Distribution

  • 00630414600444 ()
10995628

  • Insulin IVD, kit, chemiluminescent immunoassay
C-Peptide (CpS) Atellica IM - Master Curve Material Kit 10 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995543
In Commercial Distribution

  • 00630414600437 ()
10995543

  • C-peptide IVD, control
C-Peptide (CpS) Calibrator Atellica IM - CAL (2PK) 2 x 2 x 5.0mL
Siemens Healthcare Diagnostics Inc.
10995542
In Commercial Distribution

  • 00630414600420 ()
  • 00630414190945 ()
10995542

  • C-peptide IVD, calibrator
C-Peptide (CpS) Atellica IM - RGT 100T
Siemens Healthcare Diagnostics Inc.
10995541
In Commercial Distribution

  • 00630414600413 ()
10995541

  • C-peptide IVD, kit, chemiluminescent immunoassay
CHIV - Atellica IM - RGT - 100T
Siemens Healthcare Diagnostics Inc.
10995459
In Commercial Distribution

  • 00630414600390 ()
10995459

  • HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay
Ancillary Probe Wash (APW1) Atellica IM - CONS 2x25 mL
Siemens Healthcare Diagnostics Inc.
10995458
In Commercial Distribution

  • 00630414600383 ()
  • 00630414007281 ()
10995458

  • Buffered wash solution IVD
HBsAg (HBs) (1-pack) 200T Assay Kit
Siemens Healthcare Diagnostics Inc.
10309057
In Commercial Distribution

  • 00630414472867 ()
3393362

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
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