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Blood Establishment Computer Software, User Developed
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QFR
Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties
2
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QHR
Blood Grouping Reagent
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QHS
Anti-Human Globulin
U
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QHT
Reagent Red Blood Cells
U
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KSJ
System, Identification, Hepatitis B Antigen
3
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Tray, Leukocyte Typing
N
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Monitor,Test,Hiv-1
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Antibody To Htlv-1, Elisa
3
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2
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MTS
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Monoclonal, Hiv-1
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3
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Kit, Test, Saliva, Hiv-1&2
3
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MYK
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Test, Platelet Antibody
2
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N
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MYS
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MYW
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MYY
Separator, Semi-Automated, Blood Component
1
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MZH
Test, Quantitative, For Hla, Non-Diagnostic
N
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MZI
Test, Qualitative, For Hla, Non-Diagnostic
U
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MZJ
System, Concentration, Hematopoietic Stem Cell
3
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MZK
System, Separation, Hematopoietic Stem Cell
3
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NDV
Test, Ecarin Clotting Time (Ect)
F
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OTQ
Research Use Only/Hematology Devices
N
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OVG
Magnetic Cell Selection System For Cd34+ Cells From Hpc-Apheresis Used In Treatment Of Acute Myeloid Leukemia (Aml)
F
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PBA
Ecarin Clotting Time
F
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PCZ
Investigational Use Only - Immunology
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PDC
Investigational Use Only - Hematology
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PEP
Molecular Erythrocyte Typing Test
3
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Illuminator System For Blood Products
3
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PZT
Peripheral Blood Processing Device For Osteoarthritis
N
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PZU
Bone Marrow Processing Device For Clinical Use
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PZV
Peripheral Blood Processing Device For Clinical Use
N
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QBG
Assay, Oral Direct Thrombin Inhibitor
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QCZ
Mechanical And Enzymatic Autologous Skin Processor For Cell Suspension, With Applicator
3
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QPW
Reagents And Transportation Supplies, Sodium Citrate Blood Specimen Collection Tube
N
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QTY
Von Willebrand Factor Assay
2
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QWY
Mechanical And Enzymatic Autologous Skin Processor For Cell Suspension, For Stable Vitiligo, With Applicator
3
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SAC
Adamts13 Activity Test System
2
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QZV
Pediatric Extracorporeal Synthetic Semipermeable Membrane Cartridge For Acute Kidney Injury
3
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SAL
Device, Automated Cell Locating, Bone Marrow
3
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SCK
Ldt, Non-Molecular Antisera For Rare Rbc Antigens When There Is No Alternative Ivd
N
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Miscellaneous
Subpart B—Biological Stains
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Subpart B—Diagnostic Devices
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Subpart F—General Hospital and Personal Use Therapeutic Devices
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Subpart G—Manual Hematology Devices
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Subpart G—Tumor Associated Antigen immunological Test Systems
CFR Sub-Part
Subpart H—Hematology Kits and Packages
CFR Sub-Part
Subpart I—Hematology Reagents
CFR Sub-Part
Subpart J—Products Used In Establishments That Manufacture Blood and Blood Products
CFR Sub-Part
Subpart K—Products Used In Establishments That Manufacture Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
CFR Sub-Part
Immunology
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Last synced on 18 April 2025 at 11:05 pm
HE
/
HE-misc
/
QZV
View Source
Pediatric Extracorporeal Synthetic Semipermeable Membrane Cartridge For Acute Kidney Injury
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FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Miscellaneous
OYT
Blood Establishment Computer Software, User Developed
QFR
Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties
QHR
Blood Grouping Reagent
QHS
Anti-Human Globulin
QHT
Reagent Red Blood Cells
KSJ
System, Identification, Hepatitis B Antigen
MTH
Tray, Leukocyte Typing
MTK
Kit, Sample Collection, Hiv
MTL
Monitor,Test,Hiv-1
MTN
Test, Syphilis, Treponemal
MTO
Software, Management, Microplate Assay
MTP
Antibody To Htlv-1, Elisa
MTQ
Software, Blood Virus Applications
MTR
Progenitor Cell Enumeration
MTS
Vials, Challenge, Endotoxin
MVW
Kit, Western Blot, Hiv-1
MVX
Antibody, Monoclonal Blocking, Hiv-1
MVY
Monoclonal, Hiv-1
MVZ
System, Test, Home, Hiv-1
MWB
Kit, Test, Saliva, Hiv-1&2
MWO
Reagent, Blood Bank, Quality Control
MYK
Kit, Cord Blood Collection
MYP
Test, Platelet Antibody
MYQ
Kit, Antibody, Elution
MYS
Device, Ahf, Automated Cryoprecipitation
MYW
Irradiation, Blood Indicators
MYY
Separator, Semi-Automated, Blood Component
MZH
Test, Quantitative, For Hla, Non-Diagnostic
MZI
Test, Qualitative, For Hla, Non-Diagnostic
MZJ
System, Concentration, Hematopoietic Stem Cell
MZK
System, Separation, Hematopoietic Stem Cell
NDV
Test, Ecarin Clotting Time (Ect)
OTQ
Research Use Only/Hematology Devices
OVG
Magnetic Cell Selection System For Cd34+ Cells From Hpc-Apheresis Used In Treatment Of Acute Myeloid Leukemia (Aml)
PBA
Ecarin Clotting Time
PCZ
Investigational Use Only - Immunology
PDC
Investigational Use Only - Hematology
PEP
Molecular Erythrocyte Typing Test
PJF
Illuminator System For Blood Products
PZT
Peripheral Blood Processing Device For Osteoarthritis
PZU
Bone Marrow Processing Device For Clinical Use
PZV
Peripheral Blood Processing Device For Clinical Use
QBG
Assay, Oral Direct Thrombin Inhibitor
QCZ
Mechanical And Enzymatic Autologous Skin Processor For Cell Suspension, With Applicator
QPW
Reagents And Transportation Supplies, Sodium Citrate Blood Specimen Collection Tube
QTY
Von Willebrand Factor Assay
QWY
Mechanical And Enzymatic Autologous Skin Processor For Cell Suspension, For Stable Vitiligo, With Applicator
SAC
Adamts13 Activity Test System
QZV
Pediatric Extracorporeal Synthetic Semipermeable Membrane Cartridge For Acute Kidney Injury
SAL
Device, Automated Cell Locating, Bone Marrow
SCK
Ldt, Non-Molecular Antisera For Rare Rbc Antigens When There Is No Alternative Ivd
Submissions with No Product Code
Subpart B—Biological Stains
Subpart B—Diagnostic Devices
Subpart C—Cell And Tissue Culture Products
Subpart C—Clinical Laboratory Instruments
Subpart E—Specimen Preparation Reagents
Subpart F—Automated and Semi-Automated Hematology Devices
Subpart F—General Hospital and Personal Use Therapeutic Devices
Subpart F—Immunological Test Systems
Subpart G—Manual Hematology Devices
Subpart G—Tumor Associated Antigen immunological Test Systems
Subpart H—Hematology Kits and Packages
Subpart I—Hematology Reagents
Subpart J—Products Used In Establishments That Manufacture Blood and Blood Products
Subpart K—Products Used In Establishments That Manufacture Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
HE
/
HE-misc
/
QZV
View Source
Pediatric Extracorporeal Synthetic Semipermeable Membrane Cartridge For Acute Kidney Injury
Page Type
Product Code
MAUDE Alerts
View and Sign Up For MAUDE Alerts
Loading...