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Anesthesiology
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Cardiovascular
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Chemistry
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Dental
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Gastroenterology and Urology
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General Hospital
Review Panel
Hematology
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Biological Stains
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—Cell And Tissue Culture Products
CFR Sub-Part
Subpart C—Clinical Laboratory Instruments
CFR Sub-Part
Subpart E—Specimen Preparation Reagents
CFR Sub-Part
Subpart F—Automated and Semi-Automated Hematology Devices
CFR Sub-Part
Subpart F—General Hospital and Personal Use Therapeutic Devices
CFR Sub-Part
Subpart F—Immunological Test Systems
CFR Sub-Part
Subpart G—Manual Hematology Devices
CFR Sub-Part
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
BSA
Warmer, Blood, Electromagnetic Radiation
3
Product Code
BSB
Warmer, Blood, Non-Electromagnetic Radiation
2
Product Code
GKT
Separator, Automated, Blood Cell, Diagnostic
2
Product Code
KSB
Set, Transfer (Blood/Plasma)
2
Product Code
KSD
Device, Heat-Sealing
1
Product Code
KSE
Refrigerator, Freezer, Blood Storage
2
Product Code
KSF
Kit, Quality Control For Blood Banking Reagents
2
Product Code
KSG
Media, Potentiating For In Vitro Diagnostic Use
2
Product Code
KSH
Chamber, Environmental For The Storage Of Platelet Concentrate
2
Product Code
KSI
Lectins And Protectins
2
Product Code
KSK
Solution, Stabilized Enzyme
2
Product Code
KSL
Solution, Copper Sulfate For Specific Gravity Determinations
1
Product Code
KSM
System, Test, Combs, Automated
2
Product Code
KSN
Centrifuge, Cell-Washing, Automated For Immuno-Hematology
2
Product Code
KSO
Centrifuge, Blood-Bank For In Vitro Diagnostic Use
1
Product Code
KSP
Apparatus, Cell-Freezing And Reagents
1
Product Code
KSQ
Device, Blood Mixing And Blood Weighing
1
Product Code
KSR
Container, Empty, For Collection & Processing Of Blood & Blood Components
2
Product Code
KSS
Supplies, Blood-Bank
1
Product Code
KST
System, Blood Collection, Vacuum-Assisted, Manual
1
Product Code
KSW
System, Processing For Frozen Blood
2
Product Code
KSX
Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use
2
Product Code
KSY
Boxes, View, Blood Grouping
1
Product Code
KSZ
System, Test, Automated Blood Grouping And Antibody
2
Product Code
KZL
Device, Warming. Blood And Plasma
2
Product Code
MMH
Blood Establishment Computer Software And Accessories
2
Product Code
MYJ
Device, Mixing And Weighing, Semi-Automated
2
Product Code
MYX
System, Blood Collection, Vacuum-Assisted, Automated
1
Product Code
OQX
Self-Contained Blood Grouping
2
Product Code
ORG
Platelet And Plasma Separator For Bone Graft Handling
2
Product Code
PBC
Manual Blood Grouping And Antibody Test Systems
2
Product Code
PKG
Bone Marrow Processing Device To Support Hematopoietic Reconstitution
2
Product Code
PMQ
Peripheral Blood Processing Device For Wound Management
2
Product Code
QYC
Container System For The Processing And Storage Of Red Blood Cell Components Under Reduced Oxygen Conditions
2
Product Code
Subpart K—Products Used In Establishments That Manufacture Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
CFR Sub-Part
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 9 May 2025 at 11:05 pm
HE
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subpart-j—products-used-in-establishments-that-manufacture-blood-and-blood-products
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PBC
View Source
Manual Blood Grouping And Antibody Test Systems
Page Type
Product Code
MAUDE Alerts
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FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Miscellaneous
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
BSA
Warmer, Blood, Electromagnetic Radiation
BSB
Warmer, Blood, Non-Electromagnetic Radiation
GKT
Separator, Automated, Blood Cell, Diagnostic
KSB
Set, Transfer (Blood/Plasma)
KSD
Device, Heat-Sealing
KSE
Refrigerator, Freezer, Blood Storage
KSF
Kit, Quality Control For Blood Banking Reagents
KSG
Media, Potentiating For In Vitro Diagnostic Use
KSH
Chamber, Environmental For The Storage Of Platelet Concentrate
KSI
Lectins And Protectins
KSK
Solution, Stabilized Enzyme
KSL
Solution, Copper Sulfate For Specific Gravity Determinations
KSM
System, Test, Combs, Automated
KSN
Centrifuge, Cell-Washing, Automated For Immuno-Hematology
KSO
Centrifuge, Blood-Bank For In Vitro Diagnostic Use
KSP
Apparatus, Cell-Freezing And Reagents
KSQ
Device, Blood Mixing And Blood Weighing
KSR
Container, Empty, For Collection & Processing Of Blood & Blood Components
KSS
Supplies, Blood-Bank
KST
System, Blood Collection, Vacuum-Assisted, Manual
KSW
System, Processing For Frozen Blood
KSX
Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use
KSY
Boxes, View, Blood Grouping
KSZ
System, Test, Automated Blood Grouping And Antibody
KZL
Device, Warming. Blood And Plasma
MMH
Blood Establishment Computer Software And Accessories
MYJ
Device, Mixing And Weighing, Semi-Automated
MYX
System, Blood Collection, Vacuum-Assisted, Automated
OQX
Self-Contained Blood Grouping
ORG
Platelet And Plasma Separator For Bone Graft Handling
PBC
Manual Blood Grouping And Antibody Test Systems
PKG
Bone Marrow Processing Device To Support Hematopoietic Reconstitution
PMQ
Peripheral Blood Processing Device For Wound Management
QYC
Container System For The Processing And Storage Of Red Blood Cell Components Under Reduced Oxygen Conditions
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
/
subpart-j—products-used-in-establishments-that-manufacture-blood-and-blood-products
/
PBC
View Source
Manual Blood Grouping And Antibody Test Systems
Page Type
Product Code
MAUDE Alerts
View and Sign Up For MAUDE Alerts
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