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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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100SH 13X18CM E BLUE X-RAY WB
CARESTREAM HEALTH, INC.
E Blue X-ray Film WB
In Commercial Distribution

  • 60889976045534 ()
  • 40889976045530 ()
  • 00889976045532 ()
6045538

  • Medical x-ray film, screen
100SH 30X35CM GREEN X-RAY WB
CARESTREAM HEALTH, INC.
Green X-ray Film WB
In Commercial Distribution

  • 60889971706225 ()
  • 40889971706221 ()
  • 00889971706223 ()
1706225

  • Medical x-ray film, screen
100SH 35X43-14X17 DUPLICATING WB
CARESTREAM HEALTH, INC.
DUP Film WB
In Commercial Distribution

  • 60889971354440 ()
  • 40889971354446 ()
  • 00889971354448 ()
1354448

  • Medical x-ray film, non-screen
100SH 35X35-14X14 GREEN X-RAY WB 8389
CARESTREAM HEALTH, INC.
Green X-ray Film WB
In Commercial Distribution

  • 60889971096210 ()
  • 40889971096216 ()
  • 00889971096218 ()
1096213

  • Medical x-ray film, screen
100SH 11X14IN GREEN X-RAY WB
CARESTREAM HEALTH, INC.
Green X-ray Film WB
In Commercial Distribution

  • 60889971084477 ()
  • 40889971084473 ()
  • 00889971084475 ()
1084474

  • Medical x-ray film, screen
100SH 10X12IN DUPLICATING WB
CARESTREAM HEALTH, INC.
DUP Film WB
In Commercial Distribution

  • 60889971043214 ()
  • 40889971043210 ()
  • 00889971043212 ()
1043215

  • Medical x-ray film, non-screen
100SH 24X30CM GREEN X-RAY WB
CARESTREAM HEALTH, INC.
Green X-ray Film WB
In Commercial Distribution

  • 60889978497751 ()
  • 40889978497757 ()
  • 00889978497759 ()
8497752

  • Medical x-ray film, screen
For in vitro diagnostic use as a control to monitor the performance of multi- parameter hematology instruments. Boule Con-Diff Hematology Control is prepared from stabilized human blood so that repeated measurements can be made daily to monitor the performance of hematology analyzer systems. ASSIGNED VALUES and EXPECTED RANGES are determined on systems using specific Boule reagents. ASSIGNED VALUES are confirmed by multiple analysis of the control product.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
12 x 4.5mL
In Commercial Distribution

  • 00812137011299 ()
  • 00812137011817 ()
501-608

  • Full blood count IVD, control
CDS Hematology Calibrator is manufactured for calibration of multi-parameter hematology analyzers for WBC, RBC, Hgb, MCV, Plt and MPV, as applicable to the analyzer system. Multi-parameter hematology analyzers require periodic calibration in order to produce accurate results on patient samples. Calibration may be accomplished by transferring calibration factors to the analyzer through fresh blood samples that have been assayed by reference methods. However, a more direct and convenient approach is to use a calibrator material such as CDS Hematology Calibrator, having system-specific assigned values, derived from a carefully calibrated analyzer or group of analyzers. CDS Hematology Calibrator assigned values are derived from replicate analyses on whole blood calibrated hematology analyzers (see reference procedures). Replicate analyses are performed on the user’s analyzer and calibration factors are computed by comparing recovered values and assigned values. The CDS Hematology Calibrator values are then divided by these determined factors to provide calibration settings for making adjustments to the instrument. Hct, MCH, MCHC, RDW and the WBC differential parameters do not require calibration.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
1 x 4.5mL
In Commercial Distribution

  • 00812137010421 ()
502-068

  • Full blood count IVD, calibrator
For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. CDS 3PD Hematology Control is prepared from stabilized human blood so that repeated measurements can be made daily to monitor the performance of hematology analyzer systems. ASSIGNED VALUES and EXPECTED RANGES are determined on systems using specific CDS reagents. ASSIGNED VALUES are confirmed by multiple analysis of the control product and should be considered a suggested average until you establish your own running mean.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
Tri-Pack 6x4.5 mL
In Commercial Distribution

  • 00812137010414 ()
  • 00812137011789 ()
502-066

  • Full blood count IVD, control
CDS Hematology Calibrator is manufactured for calibration of multi-parameter hematology analyzers for WBC, RBC, Hgb, MCV, Plt and MPV, as applicable to the analyzer system. Multi-parameter hematology analyzers require periodic calibration in order to produce accurate results on patient samples. Calibration may be accomplished by transferring calibration factors to the analyzer through fresh blood samples that have been assayed by reference methods. However, a more direct and convenient approach is to use a calibrator material such as CDS Hematology Calibrator, having system-specific assigned values, derived from a carefully calibrated analyzer or group of analyzers. CDS Hematology Calibrator assigned values are derived from replicate analyses on whole blood calibrated hematology analyzers (see reference procedures). Replicate analyses are performed on the user’s analyzer and calibration factors are computed by comparing recovered values and assigned values. The CDS Hematology Calibrator values are then divided by these determined factors to provide calibration settings for making adjustments to the instrument. Hct, MCH, MCHC, RDW and the WBC differential parameters do not require calibration.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
1x3.0mL
In Commercial Distribution

  • 00812137010360 ()
502-040

  • Full blood count IVD, calibrator
CDS-LTX Control is used to validate volume, conductivity and light scatter parameters on COULTER HmX/ MAXM, STKS and GEN-S instruments. Prepare instrument with CDS LTX Primer immediately prior to CDS-LTX Control measurements. Accurate differential and reticulocyte measurements on COULTER HmX/MAXM, STKS and GEN-S instruments are assured by demonstrating consistent performance of volume, conductivity and light scatter parameters, using a particle of uniform size with appropriate light scattering characteristics. CDS-LTX Control validates the stability of the electrical processing and fluidic flow rate systems used to measure volume, conductivity and light scatter.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
6 x 16 mL
In Commercial Distribution

  • 00812137010254 ()
  • 00812137011824 ()
502-006

  • Reticulocyte count IVD, control
For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. CDS 3PD Hematology Control is prepared from stabilized human blood so that repeated measurements can be made daily to monitor the performance of hematology analyzer systems. ASSIGNED VALUES and EXPECTED RANGES are determined on systems using specific CDS reagents. ASSIGNED VALUES are confirmed by multiple analysis of the control product and should be considered a suggested average until you establish your own running mean.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
Tri-Pack 6x3.0mL
In Commercial Distribution

  • 00812137010247 ()
  • 00812137011770 ()
502-004

  • Full blood count IVD, control
For in vitro diagnostic use as a control to monitor the performance of multi- parameter hematology instruments. Boule Con-Diff Hematology Control is prepared from stabilized human blood so that repeated measurements can be made daily to monitor the performance of hematology analyzer systems. ASSIGNED VALUES and EXPECTED RANGES are determined on systems using specific Boule reagents. ASSIGNED VALUES are confirmed by multiple analysis of the control product.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
9 x 4.5mL
In Commercial Distribution

  • 00812137010230 ()
  • 00812137011800 ()
501-607

  • Full blood count IVD, control
Boule Cal Hematology Calibrator is manufactured for calibration multi-parameter hematology analyzers.Multi-parameter hematology analyzers require regular calibration in order to produce accurate results on patient samples. Calibration can be accomplished by transferring information to the analyzer through fresh blood samples, which have been assayed by reference methods. A more direct and convenient approach is to use a calibrator material with System Specific Values (SSV) assigned. Boule Cal is such a material. Boule Cal is a stable suspension of red blood cells, white blood cells and platelets. Assigned values are derived from replicate analyses on whole blood calibrated hematology analyzers (see reference procedures). A user analyzes Boule Cal on their instrument and computes calibration factors by comparing recovered values and assigned values. These factors provide the basis for making adjustments to the instrument.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
1 x 3.0mL
In Commercial Distribution

  • 00812137010223 ()
501-606

  • Full blood count IVD, calibrator
For in vitro diagnostic use as a control to monitor the performance of multi- parameter hematology instruments. Boule Con-Diff Tri-Level is prepared from stabilized human blood so that repeated measurements can be made daily to monitor the performance of hematology analyzer systems. ASSIGNED VALUES and EXPECTED RANGES are determined on systems using specific Boule reagents. ASSIGNED VALUES are confirmed by multiple analysis of the control product.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
6 x 4.5mL
In Commercial Distribution

  • 00812137010216 ()
  • 00812137011794 ()
501-605

  • Full blood count IVD, control
SeCore® HLA Sequencing and GSSP kits are intended for the identification and definition of Class I and II Human Leukocyte Antigens (HLA).
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117017563 ()
A15573

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
SeCore® HLA Sequencing and GSSP kits are intended for the identification and definition of Class I and II Human Leukocyte Antigens (HLA).
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117017556 ()
A15571

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
The SeCore CDx HLA Sequencing System is an in-vitro diagnostic intended to be used as a companion diagnostic for the qualitative detection of HLA alleles to aid in the selection of patients to receive specific medicinal products.
ONE LAMBDA, INC.
SECCDX-GSSP
In Commercial Distribution

  • 00812117016825 ()
SECCDX-GSSP

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
The SeCore CDx HLA Sequencing System is an in-vitro diagnostic intended to be used as a companion diagnostic for the qualitative detection of HLA alleles to aid in the selection of patients to receive specific medicinal products.
ONE LAMBDA, INC.
SECCDX-A
In Commercial Distribution

  • 00812117016818 ()
SECCDX-A

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
Bone Marrow Culture Medium with Gentamicin. 100mL bottle.
IRVINE SCIENTIFIC, LLC
91031-100ML
In Commercial Distribution

  • 00810195240569 ()
91031

  • Cell culture medium IVD
CHANG Medium MF with Gentamicin. Mitogen Free Medium for Culture of Hemopoietic Cells. 100mL bottle.
IRVINE SCIENTIFIC, LLC
91005-100ML
In Commercial Distribution

  • 00810195240545 ()
91005

  • Cell culture medium IVD
CHANG Medium BMC Bone Marrow Culture Medium. 500mL bottle.
IRVINE SCIENTIFIC, LLC
91004-500ML
In Commercial Distribution

  • 00810195240538 ()
91004

  • Cell culture medium IVD
CHANG Medium BMC Bone Marrow Culture Medium. 100mL bottle.
IRVINE SCIENTIFIC, LLC
91004-100ML
In Commercial Distribution

  • 00810195240521 ()
91004

  • Cell culture medium IVD
Freezing Medium Test Yolk Buffer (TYB) with Glycerol and Gentamicin
IRVINE SCIENTIFIC, LLC
90128-20x5ML
In Commercial Distribution

  • 00810195240163 ()
90128

  • IVF medium
Refrigeration Medium - Test Yolk Buffer (TYB) with Gentamicin
IRVINE SCIENTIFIC, LLC
90129-20x5ML
In Commercial Distribution

  • 00810195240156 ()
90129

  • IVF medium
FIT SA F03 A2 1G
SHOFU DENTAL CORPORATION
Y2571
In Commercial Distribution

  • E235Y25710 ()
Y2571

  • Dental composite resin
FIT SA F03 A1 1G
SHOFU DENTAL CORPORATION
Y2568
In Commercial Distribution

  • E235Y25680 ()
Y2568

  • Dental composite resin
FIT SA F10 A4 2.2g
SHOFU DENTAL CORPORATION
001
In Commercial Distribution

  • E235Y25630 ()
Y2563

  • Dental composite resin
FIT SA F03B1 2.2g
SHOFU DENTAL CORPORATION
001
In Commercial Distribution

  • E235Y25540 ()
Y2554

  • Dental composite resin
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