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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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SMX CEREBRAL SPINAL FLUID
UTAK LABORATORIES, INC.
35100-SMX-CSF(F)
In Commercial Distribution

  • B80035100SMXCSFF5 ()
  • B80035100SMXCSFF0 ()

  • Total Volume: 100 Milliliter
35100-SMX-CSF(F)

  • Multiple-type clinical chemistry analyte profile IVD, control
Ethanol 80mg/dL
UTAK LABORATORIES, INC.
31080
In Commercial Distribution

  • B800310805 ()
  • B800310800 ()

  • Total Volume: 3 Milliliter
31080

  • Ethanol (ETOH) IVD, control
CATECHOLAMINES LEVEL 3
UTAK LABORATORIES, INC.
20209
In Commercial Distribution

  • B800202095 ()
  • B800202090 ()

  • Total Volume: 2 Milliliter
20209

  • Multiple human hormone IVD, control
CATECHOLAMINES LEVEL 2
UTAK LABORATORIES, INC.
20208
In Commercial Distribution

  • B800202085 ()
  • B800202080 ()

  • Total Volume: 2 Milliliter
20208

  • Multiple human hormone IVD, control
CATECHOLAMINES LEVEL 1
UTAK LABORATORIES, INC.
20207
In Commercial Distribution

  • B800202075 ()
  • B800202070 ()

  • Total Volume: 2 Milliliter
20207

  • Multiple human hormone IVD, control
DEXAMETHASONE LEVEL 3
UTAK LABORATORIES, INC.
20199
In Commercial Distribution

  • B800201995 ()
  • B800201990 ()

  • Total Volume: 3 Milliliter
20199

  • Multiple steroid hormone IVD, control
DEXAMETHASONE LEVEL 2
UTAK LABORATORIES, INC.
20198
In Commercial Distribution

  • B800201985 ()
  • B800201980 ()

  • Total Volume: 3 Milliliter
20198

  • Multiple steroid hormone IVD, control
DEXAMETHASONE LEVEL 1
UTAK LABORATORIES, INC.
20197
In Commercial Distribution

  • B800201972 ()
  • B800201970 ()

  • Total Volume: 3 Milliliter
20197

  • Multiple steroid hormone IVD, control
ETG Plus Level 2
UTAK LABORATORIES, INC.
13021
In Commercial Distribution

  • B800130215 ()
  • B800130210 ()

  • Total Volume: 5 Milliliter
13021

  • Ethyl glucuronide (EtG) IVD, control
ETG Plus Level 1
UTAK LABORATORIES, INC.
13020
In Commercial Distribution

  • B800130205 ()
  • B800130200 ()

  • Total Volume: 5 Milliliter
13020

  • Ethyl glucuronide (EtG) IVD, control
BLANK HAIR MATRIX
UTAK LABORATORIES, INC.
115110(50) SMXH F AH
In Commercial Distribution

  • B80011511050SMXHFAH5 ()
  • B80011511050SMXHFAH0 ()

  • Total Volume: 50 Milliliter
115110(50) SMXH F AH

  • Multiple-type clinical chemistry analyte profile IVD, control
WHOLE BLOOD
UTAK LABORATORIES, INC.
111120-WB(F)2.5
In Commercial Distribution

  • B800111120WBF255 ()
  • B800111120WBF250 ()

  • Total Volume: 2.5 Milliliter
111120-WB(F)2.5

  • Multiple-type clinical chemistry analyte profile IVD, control
Fentanyl Analogues 2ng/mL
UTAK LABORATORIES, INC.
10189
In Commercial Distribution

  • B800101895 ()
  • B800101890 ()

  • Total Volume: 3 Milliliter
10189

  • Multiple therapeutic drugs/drugs of abuse IVD, control
Fentanyl Analogues 5ng/mL
UTAK LABORATORIES, INC.
10186
In Commercial Distribution

  • B800101865 ()
  • B800101860 ()

  • Total Volume: 3 Milliliter
10186

  • Multiple therapeutic drugs/drugs of abuse IVD, control
BLANK HAIR MATRIX
UTAK LABORATORIES, INC.
034765-0001
In Commercial Distribution

  • B80003476500010 ()

  • Total Volume: 100 Milliliter
BLK HAIR OL

  • Multiple therapeutic drugs/drugs of abuse IVD, control
No Description
IMMUCOR GTI DIAGNOSTICS, INC.
628075
In Commercial Distribution

  • 10888234400134 ()
628075

  • DNA amplification enzyme reagent IVD
Checkcell (Weak) is used to confirm the validity of negative antiglobulin tests. Checkcell (Weak) is a single vial pool of group O red blood cells that have been sensitized with an IgG antibody. This product is the one (1) vial configuration.
IMMUCOR, INC.
0002226
In Commercial Distribution

  • 10888234000204 ()
0002226

  • Multiple immunohaematology test IVD, control
Checkcell is used to confirm the validity of negative antiglobulin tests. Checkcell is a single vial pool of group O red blood cells that have been sensitized with an IgG antibody. This product is the three (3) vial configuration.
IMMUCOR, INC.
0002225
In Commercial Distribution

  • 10888234000198 ()
0002225

  • Multiple immunohaematology test IVD, control
Checkcell is used to confirm the validity of negative antiglobulin tests. Checkcell is a single vial pool of group O red blood cells that have been sensitized with an IgG antibody. This product is the one (1) vial configuration.
IMMUCOR, INC.
0002224
In Commercial Distribution

  • 10888234000181 ()
0002224

  • Multiple immunohaematology test IVD, control
Hemantigen (Pooled Cells) is used in the detection of unexpected red blood cell blood group antibodies for blood donors. Hemantigen is a single vial pool of equal amounts of reagent red blood cells from two (2) group O donors.
IMMUCOR, INC.
0002223
In Commercial Distribution

  • 10888234000174 ()
0002223

  • Pooled antibody screening reagent red blood cell IVD, antigen
ImmuAdd is intended for use as a potentiator in antibody detection, antibody identification and compatibility procedures. This product is prepared from glycine and salt-poor bovine albumin, and is the ten (10) vial configuration.
IMMUCOR, INC.
0002008
In Commercial Distribution

  • 10888234000167 ()
0002008

  • Bovine serum albumin (BSA) immunohaematology reagent IVD
A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 1 vial of CD4L level.
STRECK, INC.
213330
In Commercial Distribution

  • 10844509000096 ()

  • Total Volume: 2.5 Milliliter
213330

  • Multiple CD cell marker IVD, control
A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 1 vial of Normal level.
STRECK, INC.
213325
In Commercial Distribution

  • 10844509000089 ()

  • Total Volume: 2.5 Milliliter
213325

  • Multiple CD cell marker IVD, control
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
997-61501
Not in Commercial Distribution

  • 10856626006189 ()
  • 00856626006182 ()
997-61501

  • Alpha-fetoprotein-L3 fraction (AFP-L3) IVD, kit, fluorescent immunoassay
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
997-61001
Not in Commercial Distribution

  • 10856626006172 ()
  • 00856626006175 ()
997-61001

  • Alpha-fetoprotein-L3 fraction (AFP-L3) IVD, control
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
995-61301
Not in Commercial Distribution

  • 10856626006134 ()
  • 00856626006137 ()
995-61301

  • Des-gamma-carboxyprothrombin (DCP) IVD, control
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
993-61101
Not in Commercial Distribution

  • 10856626006073 ()
  • 00856626006076 ()
993-61101

  • Alpha-fetoprotein-L3 fraction (AFP-L3) IVD, control
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
991-61401
Not in Commercial Distribution

  • 10856626006066 ()
  • 00856626006069 ()
991-61401

  • Des-gamma-carboxyprothrombin (DCP) IVD, control
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
990-28011
Not in Commercial Distribution

  • 10856626006035 ()
  • 00856626006038 ()
990-28011

  • High density lipoprotein (HDL) cholesterol IVD, calibrator
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
464-01601
Not in Commercial Distribution

  • 10856626006028 ()
  • 00856626006021 ()
464-01601

  • Triglyceride IVD, calibrator
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
276-76491
Not in Commercial Distribution

  • 10856626006011 ()
  • 00856626006014 ()
276-76491

  • Non-esterified fatty acid IVD, calibrator
A ZOICX Additive Sterile Filtered
Incell Corporation, LLC
ZDAN04
In Commercial Distribution

  • G507ZDAN040 ()
ZDAN04

  • Cell culture medium IVD
No Description
SEPTODONT, INC
01C2080
In Commercial Distribution

  • 00303620000857 ()

  • Weight: 4.5 Gram


  • Dental etching solution
  • Dental composite resin
  • Dentine adhesive
No Description
SEPTODONT, INC
01C2030
In Commercial Distribution

  • 00303620000611 ()

  • Total Volume: 5 Milliliter
01C2030

  • Dentine adhesive
Anti-S (Monoclonal) Gamma-clone reagent is intended for the detection of the S (MNS3) antigen on red blood cells by tube test.
IMMUCOR, INC.
0066428
In Commercial Distribution

  • 10888234002437 ()
0066428

  • Anti-S [MNS003] red blood cell grouping IVD, antibody
Anti-s (Monoclonal) Gamma-clone reagent is intended for the detection of the s (MNS4) antigen on red blood cells by tube test.
IMMUCOR, INC.
0066429
In Commercial Distribution

  • 10888234002420 ()
0066429

  • Anti-S [MNS004] red blood cell grouping IVD, antibody
Panoscreen EXTEND is intended for use in the detection of unexpected red blood cell blood group antibodies.
IMMUCOR, INC.
0002383
In Commercial Distribution

  • 10888234002406 ()


  • Antibody identification panel reagent red blood cell IVD, kit, agglutination
Anti-k (Monoclonal) (IgG) Gamma-clone Blood Grouping Reagent is intended for the detection of the k (KEL2) antigen on red blood cells by indirect agglutination tube test. This product configuration is a single vial.
IMMUCOR, INC.
0004817
In Commercial Distribution

  • 10888234002390 ()
0004817

  • Anti-k (KEL002) red blood cell grouping IVD, antibody
Anti-Fyb (Monoclonal) Gamma-clone Blood Grouping Reagent is intended for the detection of the Fyb (FY2) antigen on red blood cells by direct agglutination tube test. This product configuration is a single vial.
IMMUCOR, INC.
0004818
In Commercial Distribution

  • 10888234002383 ()
0004818

  • Anti-Fy^b red blood cell grouping IVD, antibody
Anti-Cw (Monoclonal) Gamma-clone Blood Grouping Reagent is intended for the detection of the Cw (RH8) antigen on red blood cells by direct agglutination tube test. This product configuration is a single vial.
IMMUCOR, INC.
0004819
In Commercial Distribution

  • 10888234002376 ()
0004819

  • Anti-C^w red blood cell grouping IVD, antibody
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