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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Di(a+) Cell is used in the detection of unexpected red blood cell blood group antibodies. Di(a+) Cell is a single vial of group O, Di(a+) red blood cells.
IMMUCOR, INC.
0005021
In Commercial Distribution

  • 10888234000471 ()
0005021

  • Di^a positive reagent red blood cell IVD, antigen
Belle Navy Spectacle
Kenmark Optical, Inc.
BLLENV51
In Commercial Distribution

  • 00715317002240 ()


  • Prescription spectacles
Belle Navy Spectacle
Kenmark Optical, Inc.
BLLENV49
In Commercial Distribution

  • 00715317002233 ()


  • Prescription spectacles
Belle Cheetah Spectacle
Kenmark Optical, Inc.
BLLECH51
In Commercial Distribution

  • 00715317002110 ()


  • Prescription spectacles
Belle Cheetah Spectacle
Kenmark Optical, Inc.
BLLECH49
In Commercial Distribution

  • 00715317002103 ()


  • Prescription spectacles
Belle Emerald Spectacle
Kenmark Optical, Inc.
BLLEEM51
In Commercial Distribution

  • 00715317002059 ()


  • Prescription spectacles
Belle Emerald Spectacle
Kenmark Optical, Inc.
BLLEEM49
In Commercial Distribution

  • 00715317002042 ()


  • Prescription spectacles
Scanner S900 ARTI
ZIRKONZAHN SRL
BG001545
In Commercial Distribution

  • D800BG001545 ()


  • Dental milling system, CAD/CAM, laboratory
Scanner S600 ARTI
ZIRKONZAHN SRL
BG000838
In Commercial Distribution

  • D800BG000838 ()


  • Dental milling system, CAD/CAM, laboratory
Hemo-QC simulates blood samples and is intended for the daily quality control of routine blood bank reagents used in manual, semi-automated and automated blood typing and antibody screen test systems.
HEMO BIOSCIENCE INC
H9200
In Commercial Distribution

  • 00858352006009 ()
H9200

  • Multiple blood group genotyping IVD, control
The ID CORE CONTROL kit consists of 2 sets of recombinant synthetic DNA plasmids to be used as positive controls to evaluate the performance of the ID CORE XT test(Kit Product Number: 1021720000). The ID CORE CONTROL kit contains two separate vials: ID CORE CONTROL 1 and ID CORE CONTROL 2, both composed of synthetic plasmid pools to be used as assayed positive controls for alternate alleles (alleles 1 and 2, respectively) of the 29 polymorphisms assayed by ID CORE XT. Both control vials must be used in every run of the ID CORE XT test as positive controls for the correct detection of the polymorphism genotypes interrogated by the test. Each control has expected polymorphism genotypes results in the ID CORE XT test when analyzed by the ID CORE XT ANALYSIS SOFTWARE and will produce a valid or invalid run result. ID CORE XT is a qualitative, polymerase chain reaction (PCR) and hybridization-based genotyping test for the simultaneous identification of multiple alleles encoding human erythrocyte antigens (HEAs) in human genomic DNA. ID CORE XT interrogates 29 polymorphisms to predict 53 HEA allele genotypes and 37 antigen phenotypes of the following blood group systems: Rh, Kell, Kidd, Duffy, MNS, Diego, Dombrock, Colton, Cartwright and Lutheran, as an alternative to serology.
PROGENIKA BIOPHARMA, SA
v1
In Commercial Distribution

  • 08437013457040 ()
1301790000

  • Multiple blood group genotyping IVD, control
ID CORE XT (Reagents and Analysis Software) is a qualitative, polymerase chain reaction (PCR) and hybridization-based genotyping test for the simultaneous identification of multiple alleles encoding human erythrocyte antigens (HEAs) in genomic DNA extracted from whole blood specimens collected in EDTA. This test can be used to genotype 29 polymorphisms and predict 37 HEA phenotypes of blood group systems Rh (CW, C, c, E, e, VS, V, hrB, hrS), Kell (K, k, Kpa, Kpb, Jsa, Jsb), Kidd (Jka, Jkb), Duffy (Fya, Fyb), MNS (M, N, S, s, U, Mia), Diego (Dia, Dib), Dombrock (Doa, Dob, Hy, Joa), Colton (Coa, Cob), Cartwright (Yta, Ytb), and Lutheran (Lua, Lub) as an alternative to serology. The ID CORE XT test relies on allele-specific probes attached to color-coded microspheres, which hybridize specifically to the labeled PCR products. A subsequent fluorescent labeling step allows detection and quantification of the hybridization signal. ID CORE XT generates a simultaneous multiplex reaction in a single well, avoiding the need to run separate methods in parallel. The software outcome is a polymorphism genotype, a predicted allele genotype and a predicted phenotype, bypassing any subjective interpretation of the results.
PROGENIKA BIOPHARMA, SA
v3
In Commercial Distribution

  • 08437013457019 ()
1021720000

  • Multiple blood group genotyping IVD, nucleic acid technique (NAT)
No Description
BIOARRAY SOLUTIONS LTD
800-20236
In Commercial Distribution

  • 10888234102632 ()
800-20236

  • Multiple blood group genotyping IVD, control
No Description
BIOARRAY SOLUTIONS LTD
800-20202-96
In Commercial Distribution

  • 10888234102618 ()
800-20202-96

  • Multiple blood group genotyping IVD, nucleic acid technique (NAT)
No Description
BIOARRAY SOLUTIONS LTD
800-00229
In Commercial Distribution

  • 10888234102328 ()
800-00229

  • Multiple blood group genotyping IVD, control
No Description
BIOARRAY SOLUTIONS LTD
800-00228
In Commercial Distribution

  • 10888234102298 ()
800-00228

  • Multiple blood group genotyping IVD, control
No Description
BIOARRAY SOLUTIONS LTD
800-20202-08
In Commercial Distribution

  • 10888234100065 ()
800-20202-08

  • Multiple blood group genotyping IVD, nucleic acid technique (NAT)
This reagent is used for the detection of the Di(a) antigen on red blood cells by tube test. This product configuration is a single vial.
IMMUCOR, INC.
0007620
In Commercial Distribution

  • 10888234000839 ()
0007620

  • Anti-Di^a red blood cell grouping IVD, antibody
No Description
BIOARRAY SOLUTIONS LTD
800-10242
In Commercial Distribution

  • 10888234100928 ()
800-10242

  • Multiple blood group genotyping IVD, reagent
No Description
BIOARRAY SOLUTIONS LTD
800-00287
In Commercial Distribution

  • 10888234100836 ()
800-00287

  • Multiple blood group genotyping IVD, reagent
No Description
BIOARRAY SOLUTIONS LTD
800-00195
In Commercial Distribution

  • 10888234100683 ()
800-00195

  • Multiple blood group genotyping IVD, reagent
No Description
BIOARRAY SOLUTIONS LTD
800-00194
In Commercial Distribution

  • 10888234100669 ()
800-00194

  • Multiple blood group genotyping IVD, reagent
No Description
BIOARRAY SOLUTIONS LTD
800-00193
In Commercial Distribution

  • 10888234100645 ()
800-00193

  • Multiple blood group genotyping IVD, reagent
No Description
BIOARRAY SOLUTIONS LTD
800-00191
In Commercial Distribution

  • 10888234100621 ()
800-00191

  • Multiple blood group genotyping IVD, reagent
Dongle for Scanner S600 ARTI
ZIRKONZAHN SRL
ZBAC1401
In Commercial Distribution

  • ZBAC1401 ()


  • Dental milling system, CAD/CAM, laboratory
Scanner S600 ARTI V0/V1
ZIRKONZAHN SRL
BGAP0210
In Commercial Distribution

  • D800BGAP0210 ()


  • Dental milling system, CAD/CAM, laboratory
Scanner S300 ARTI with Scansoftware
ZIRKONZAHN SRL
SYAB0600
In Commercial Distribution

  • D800SYAB0600 ()


  • Dental milling system, CAD/CAM, laboratory
Scanner S300 ARTI 230V Messe-allgemein
ZIRKONZAHN SRL
WRAA9670
In Commercial Distribution

  • D800WRAA9670 ()


  • Dental milling system, CAD/CAM, laboratory
Scanner S300 ARTI 230V Messe-allgemein
ZIRKONZAHN SRL
WRAA9004
In Commercial Distribution

  • D800WRAA9004 ()


  • Dental milling system, CAD/CAM, laboratory
Scanner S900 ARTI 230V Messe-allgemein
ZIRKONZAHN SRL
WRAA9002
In Commercial Distribution

  • D800WRAA9002 ()


  • Dental milling system, CAD/CAM, laboratory
Scanner S600 ARTI 230V Messe-allgemein
ZIRKONZAHN SRL
WRAA9001
In Commercial Distribution

  • D800WRAA9001 ()


  • Dental milling system, CAD/CAM, laboratory
Scanner S300 ARTI without Scansoftware "exchange"
ZIRKONZAHN SRL
ERAB4061
In Commercial Distribution

  • D800ERAB4061 ()


  • Dental milling system, CAD/CAM, laboratory
Scanner S900 ARTI without Scansoftware "exchange"
ZIRKONZAHN SRL
ERAB4051
In Commercial Distribution

  • D800ERAB4051 ()


  • Dental milling system, CAD/CAM, laboratory
APOLLO DI
SIRONA Dental Systems GmbH
6418375
Not in Commercial Distribution

  • E27664183750 ()


  • CAD/CAM software
No Description
Zetta25 AG
04262352359243
In Commercial Distribution

  • 04262352359243 ()


  • CAD/CAM software
DI Scan
Zetta25 AG
04262352350035
In Commercial Distribution

  • 04262352350035 ()
S3806

  • CAD/CAM software
DI C500, Dual Imaging Color module. FL - Accessory for Leica surgical operating microscope systems
Leica Microsystems (Schweiz) AG
000000000010448306
In Commercial Distribution

  • 07630003556803 ()

  • Device Size Text, specify:


  • General-purpose surgical microscope
Scanner S600 V3 ARTI 230 V without Scansoftware "exchange"
ZIRKONZAHN SRL
ERAB4031
In Commercial Distribution

  • D800ERAB4031 ()


  • Dental milling system, CAD/CAM, laboratory
Scanner ORTHO Scan S300 Arti (part of product set)
ZIRKONZAHN SRL
BG001644
In Commercial Distribution

  • D800BG001644 ()


  • Dental milling system, CAD/CAM, laboratory
Scanner S900 ARTI with Scansoftware, excl. PC and screen
ZIRKONZAHN SRL
SYAB0910
In Commercial Distribution

  • D800SYAB0910 ()


  • Dental milling system, CAD/CAM, laboratory
BP CUFF,SC FABRIC,1T-16IN,ADULT,26-35CM
Statcorp Medical
SoftCheck BP Cuffs
In Commercial Distribution

  • 10841522109027 ()

  • 26-35 cm ID, 16" DI tubing
ST2635-16

  • Blood pressure cuff, single-use
Scanner S600 ARTI 120 V with scan software, PC and screen
ZIRKONZAHN SRL
SY0186
In Commercial Distribution

  • D800SY0186 ()


  • Dental milling system, CAD/CAM, laboratory
Scanner S600 ARTI 230 V with Scansoftware, excl. PC and screen
ZIRKONZAHN SRL
SY0160
In Commercial Distribution

  • D800SY0160 ()


  • Dental milling system, CAD/CAM, laboratory
Scanner S600 ARTI 230 V with scan Software, PC and screen
ZIRKONZAHN SRL
SY0095
In Commercial Distribution

  • D800SY0095 ()


  • Dental milling system, CAD/CAM, laboratory
Scanner S600 ARTI 120 V with Scansoftware, excl. PC and screen
ZIRKONZAHN SRL
SY0198
In Commercial Distribution

  • D800SY0198 ()


  • Dental milling system, CAD/CAM, laboratory
Scanner S900 ARTI 230 V with scan Software, PC and screen
ZIRKONZAHN SRL
SYAB0920
In Commercial Distribution

  • D800SYAB0920 ()


  • Dental milling system, CAD/CAM, laboratory
No Description
Overjet, Inc.
v1
In Commercial Distribution

  • 00860005586349 ()


  • Radiological PACS software
APOLLO DI SpeedSpray
SIRONA Dental Systems GmbH
6414572
Not in Commercial Distribution

  • E27664145722 ()


  • Dental impression tray, single-use
Leica DI C800 - Accessory for Leica surgical operating microscope systems
Leica Microsystems (Schweiz) AG
000000000010448572
In Commercial Distribution

  • 07630003569445 ()

  • Device Size Text, specify:


  • General-purpose surgical microscope
DI DLS
Ortho2, LLC
6.1.1
In Commercial Distribution

  • 00860001048506 ()


  • Radiological PACS software
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