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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A 5-part differential control that monitors all parameters, including reticulocytes and nucleated red blood cells. Contains 4 vials of high level.
STRECK, INC.
225482
In Commercial Distribution

  • 20844509000345 ()

  • Total Volume: 4.5 Milliliter
225482

  • Full blood count IVD, control
A 5-part differential control that monitors all parameters, including reticulocytes and nucleated red blood cells. Contains 4 vials of normal level.
STRECK, INC.
225481
In Commercial Distribution

  • 20844509000338 ()

  • Total Volume: 4.5 Milliliter
225481

  • Full blood count IVD, control
A 5-part differential control that monitors all parameters, including reticulocytes and nucleated red blood cells. Contains 4 vials of low level.
STRECK, INC.
225480
In Commercial Distribution

  • 20844509000321 ()

  • Total Volume: 4.5 Milliliter
225480

  • Full blood count IVD, control
A hematology calibrator assayed for the Abbott CELL-DYN® 3200, 3500, 3700 and Ruby® analyzers. Contains 1 vial.
STRECK, INC.
221106
In Commercial Distribution

  • 20844509000314 ()

  • Total Volume: 3.0 Milliliter
221106

  • Full blood count IVD, calibrator
Cell-Chex is a body fluid procedural control for red blood cell (RBC) and white blood cell (WBC) counts, crystal identification, and white blood cell differentiation. Contains 6 vials of L2.
STRECK, INC.
212424
In Commercial Distribution

  • 20844509000277 ()

  • Total Volume: 2.0 Milliliter
212424

  • Full blood count IVD, control
Cell-Chex is a body fluid procedural control for red blood cell (RBC) and white blood cell (WBC) counts, crystal identification, and white blood cell differentiation. Contains 2 vials of L1-CC.
STRECK, INC.
212429
In Commercial Distribution

  • 20844509000260 ()

  • Total Volume: 2.0 Milliliter
212429

  • Full blood count IVD, control
Cell-Chex is a body fluid procedural control for red blood cell (RBC) and white blood cell (WBC) counts, crystal identification, and white blood cell differentiation. Contains 6 vials of L1-UC.
STRECK, INC.
212432
In Commercial Distribution

  • 20844509000253 ()

  • Total Volume: 2.0 Milliliter
212432

  • Full blood count IVD, control
A hematology calibrator assayed for Beckman Coulter®, Abbott, Horiba Medical, HTI, and Mindray instruments. Contains 1 vial.
STRECK, INC.
221101
In Commercial Distribution

  • 20844509000246 ()

  • Total Volume: 3.0 Milliliter
221101

  • Full blood count IVD, calibrator
A whole blood hematology control specifically formulated for the Abbott CELL-DYN® 5-part differential instruments. Contains 4 vials of high level.
STRECK, INC.
218934
In Commercial Distribution

  • 20844509000208 ()

  • Total Volume: 3.0 Milliliter
218934

  • Full blood count IVD, control
A whole blood hematology control specifically formulated for the Abbott CELL-DYN® 5-part differential instruments. Contains 4 vials of normal level.
STRECK, INC.
218914
In Commercial Distribution

  • 20844509000192 ()

  • Total Volume: 3.0 Milliliter
218914

  • Full blood count IVD, control
A whole blood hematology control specifically formulated for the Abbott CELL-DYN® 5-part differential instruments. Contains 4 vials of low level.
STRECK, INC.
218924
In Commercial Distribution

  • 20844509000185 ()

  • Total Volume: 3.0 Milliliter
218924

  • Full blood count IVD, control
A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 2 vials of CD4L level.
STRECK, INC.
213366
In Commercial Distribution

  • 20844509000147 ()

  • Total Volume: 3.0 Milliliter
213366

  • Multiple CD cell marker IVD, control
A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 2 vials Normal level.
STRECK, INC.
213365
In Commercial Distribution

  • 20844509000130 ()

  • Total Volume: 3.0 Milliliter
213365

  • Multiple CD cell marker IVD, control
A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 2 vials of CD4L level.
STRECK, INC.
213331
In Commercial Distribution

  • 20844509000093 ()

  • Total Volume: 2.5 Milliliter
213331

  • Multiple CD cell marker IVD, control
A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 2 vials Normal level.
STRECK, INC.
213326
In Commercial Distribution

  • 20844509000086 ()

  • Total Volume: 2.5 Milliliter
213326

  • Multiple CD cell marker IVD, control
SEcure® Dentin Shade Resin Cement 9g Syringe (with 10 Tips)
PARKELL, INC.
S274
In Commercial Distribution

  • 00810000529551 ()
S274

  • Dental composite resin
SEcure® White Opaque Shade Resin Cement 9g Syringe (with 10 Tips)
PARKELL, INC.
S273
In Commercial Distribution

  • 00810000529544 ()
S273

  • Dental composite resin
SEcure® Translucent Shade Resin Cement 9g Syringe (with 10 Tips)
PARKELL, INC.
S272
In Commercial Distribution

  • 00810000529537 ()
S272

  • Dental composite resin
SEcure® Self-Etch Primer 3ml
PARKELL, INC.
S271
In Commercial Distribution

  • 00810000529520 ()
S271

  • Dental composite resin
SEcure® Resin Cement System Kit with Translucent Shade
PARKELL, INC.
S270
In Commercial Distribution

  • 00810000529513 ()
S270

  • Dental composite resin
25SH 14X36IN GREEN X-RAY WB
CARESTREAM HEALTH, INC.
Green X-ray Film WB
In Commercial Distribution

  • 60889971946270 ()
  • 40889971946276 ()
  • 00889971946278 ()
1946276

  • Medical x-ray film, screen
100SH 11X14IN BLUE X-RAY WB
CARESTREAM HEALTH, INC.
Full Blue X-ray Film WB
Not in Commercial Distribution

  • 60889971878663 ()
  • 40889971878669 ()
  • 00889971878661 ()
1878669

  • Medical x-ray film, screen
25SH 14X36IN BLUE X-RAY WB
CARESTREAM HEALTH, INC.
Full Blue X-ray Film WB
In Commercial Distribution

  • 60889971860101 ()
  • 40889971860107 ()
  • 00889971860109 ()
1860105

  • Medical x-ray film, screen
100SH 10X12IN GREEN X-RAY WB
CARESTREAM HEALTH, INC.
Green X-ray Film WB
In Commercial Distribution

  • 60889971753229 ()
  • 40889971753225 ()
  • 00889971753227 ()
1753227

  • Medical x-ray film, screen
A multi-parameter hematology control for small laboratories and point-of-care applications that perform a limited number of hematology tests. Contains 6 vials of high level.
STRECK, INC.
215436
In Commercial Distribution

  • 40844509000707 ()

  • Total Volume: 1.5 Milliliter
215436

  • Full blood count IVD, control
A multi-parameter hematology control for small laboratories and point-of-care applications that perform a limited number of hematology tests. Contains 6 vials of normal level.
STRECK, INC.
215416
In Commercial Distribution

  • 40844509000691 ()

  • Total Volume: 1.5 Milliliter
215416

  • Full blood count IVD, control
A multi-parameter hematology control for small laboratories and point-of-care applications that perform a limited number of hematology tests. Contains 6 vials of low level.
STRECK, INC.
215426
In Commercial Distribution

  • 40844509000684 ()

  • Total Volume: 1.5 Milliliter
215426

  • Full blood count IVD, control
A Multi-Parameter Assayed Hematology Control for Instruments Offering a 3-Part Differential. Contains 1 vial of high level.
STRECK, INC.
218753
In Commercial Distribution

  • 40844509000639 ()

  • Total Volume: 2.5 Milliliter
218753

  • Full blood count IVD, control
A Multi-Parameter Assayed Hematology Control for Instruments Offering a 3-Part Differential. Contains 1 vial of low level.
STRECK, INC.
218751
In Commercial Distribution

  • 40844509000622 ()

  • Total Volume: 2.5 Milliliter
218751

  • Full blood count IVD, control
A Multi-Parameter Assayed Hematology Control for Instruments Offering a 3-Part Differential. Contains 6 vials of normal level.
STRECK, INC.
218995
In Commercial Distribution

  • 40844509000615 ()

  • Total Volume: 4.5 Milliliter
218995

  • Full blood count IVD, control
A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 5 vials of CD4L level.
STRECK, INC.
213377
In Commercial Distribution

  • 40844509000523 ()

  • Total Volume: 3.0 Milliliter
213377

  • Multiple CD cell marker IVD, control
A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 5 vials of Normal level.
STRECK, INC.
213378
In Commercial Distribution

  • 40844509000516 ()

  • Total Volume: 3.0 Milliliter
213378

  • Multiple CD cell marker IVD, control
A hematology calibrator assayed for the Abbott CELL-DYN® 3200, 3500, 3700 and Ruby® analyzers. Contains 2 vials.
STRECK, INC.
221108
In Commercial Distribution

  • 40844509000318 ()

  • Total Volume: 3.0 Milliliter
221108

  • Full blood count IVD, calibrator
A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 1 vial of level CD4L
STRECK, INC.
213324
In Commercial Distribution

  • 40844509000141 ()

  • Total Volume: 3.0 Milliliter
213324

  • Multiple CD cell marker IVD, control
A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 1 vial of level Normal
STRECK, INC.
213323
In Commercial Distribution

  • 40844509000134 ()

  • Total Volume: 3.0 Milliliter
213323

  • Multiple CD cell marker IVD, control
A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 8 vials Normal level.
STRECK, INC.
213333
In Commercial Distribution

  • 40844509000080 ()

  • Total Volume: 2.5 Milliliter
213333

  • Multiple CD cell marker IVD, control
NW DOA Panel, +25%, 10mL
BIOCHEMICAL DIAGNOSTICS INC
18008623
In Commercial Distribution

  • 00810042684348 ()
18008623

  • Multiple drugs of abuse IVD, control
NW DOA Panel, -25%, 10mL
BIOCHEMICAL DIAGNOSTICS INC
18008622
In Commercial Distribution

  • 00810042684331 ()
18008622

  • Multiple drugs of abuse IVD, control
SERIES V-H, Cutoff -25%, 20mL
BIOCHEMICAL DIAGNOSTICS INC
19555252
In Commercial Distribution

  • 00810042683921 ()
19555252

  • Multiple drugs of abuse IVD, control
ORAL-SKREEN, 3X Cutoff, 6x20mL
BIOCHEMICAL DIAGNOSTICS INC
20200109-6pk
In Commercial Distribution

  • 00810042682658 ()
20200109-6pk

  • Multiple drugs of abuse IVD, control
ORAL-SKREEN , Neg/3X POSITIVE KITBOX, 2x20mL
BIOCHEMICAL DIAGNOSTICS INC
702030
In Commercial Distribution

  • 00810042682634 ()
702030

  • Multiple drugs of abuse IVD, control
Oral Fluid, 3X Cutoff, 20mL
BIOCHEMICAL DIAGNOSTICS INC
20200109
In Commercial Distribution

  • 00810042682627 ()
20200109

  • Multiple drugs of abuse IVD, control
Oral Fluid, 2X Cutoff, 20mL
BIOCHEMICAL DIAGNOSTICS INC
20200108
In Commercial Distribution

  • 00810042682610 ()
20200108

  • Multiple drugs of abuse IVD, control
Oral Fluid, Cutoff +50%, 20mL
BIOCHEMICAL DIAGNOSTICS INC
20200107
In Commercial Distribution

  • 00810042682603 ()
20200107

  • Multiple drugs of abuse IVD, control
Oral Fluid, Cutoff -50%, 20mL
BIOCHEMICAL DIAGNOSTICS INC
20200103
In Commercial Distribution

  • 00810042682597 ()
20200103

  • Multiple drugs of abuse IVD, control
A whole blood assayed hematology control that offers complete assay values for the 5-part white cell differential available with Beckman Coulter STKS™, MAXM™, HmX and LH 500. Contains 4 vials of normal level.
STRECK, INC.
225514
In Commercial Distribution

  • 30844509001158 ()

  • Total Volume: 4.0 Milliliter
225514

  • Full blood count IVD, control
A multi-parameter hematology control for small laboratories and point-of-care applications that perform a limited number of hematology tests. Contains 6 vials of high level.
STRECK, INC.
215108
In Commercial Distribution

  • 30844509000700 ()

  • Total Volume: 1.5 Milliliter
215108

  • Full blood count IVD, control
A multi-parameter hematology control for small laboratories and point-of-care applications that perform a limited number of hematology tests. Contains 6 vials of normal level.
STRECK, INC.
215107
In Commercial Distribution

  • 30844509000694 ()

  • Total Volume: 1.5 Milliliter
215107

  • Full blood count IVD, control
A multi-parameter hematology control for small laboratories and point-of-care applications that perform a limited number of hematology tests. Contains 6 vials of low level.
STRECK, INC.
215106
In Commercial Distribution

  • 30844509000687 ()

  • Total Volume: 1.5 Milliliter
215106

  • Full blood count IVD, control
A Multi-Parameter Assayed Hematology Control for Instruments Offering a 3-Part Differential. Contains 6 vials of high level.
STRECK, INC.
218994
In Commercial Distribution

  • 30844509000632 ()

  • Total Volume: 2.5 Milliliter
218994

  • Full blood count IVD, control
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