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Subpart B—Biological Stains
CFR Sub-Part
Subpart C—Cell And Tissue Culture Products
CFR Sub-Part
Subpart D—Pathology Instrumentation and Accessories
CFR Sub-Part
Subpart E—Immunology Laboratory Equipment and Reagents
CFR Sub-Part
Subpart E—Specimen Preparation Reagents
CFR Sub-Part
Subpart F—Automated and Semi-Automated Hematology Devices
CFR Sub-Part
Subpart F—Immunological Test Systems
CFR Sub-Part
DEP
Lambda, Peroxidase, Antigen, Antiserum, Control
2
Product Code
DEY
Igm, Peroxidase, Antigen, Antiserum, Control
2
Product Code
DFD
Kappa, Peroxidase, Antigen, Antiserum, Control
2
Product Code
DGH
Igd, Peroxidase, Antigen, Antiserum, Control
2
Product Code
DAA
Igg, Peroxidase, Antigen, Antiserum, Control
2
Product Code
DGO
Ige, Peroxidase, Antigen, Antiserum, Control
2
Product Code
DHF
D/Km-1, Antigen, Antiserum, Control
1
Product Code
LYE
Cytokeratins
2
Product Code
NUA
System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection
2
Product Code
PFR
System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection
2
Product Code
PFS
System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection
2
Product Code
PKB
Autosomal Recessive Carrier Screening Gene Mutation Detection System
2
Product Code
Subpart G—Tumor Associated Antigen immunological Test Systems
CFR Sub-Part
Subpart H—Hematology Kits and Packages
CFR Sub-Part
Subpart J—Products Used In Establishments That Manufacture Blood and Blood Products
CFR Sub-Part
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 23 May 2025 at 11:06 pm
PA
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subpart-f—immunological-test-systems
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PFR
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System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection
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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
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Miscellaneous
Subpart B—Biological Stains
Subpart C—Cell And Tissue Culture Products
Subpart D—Pathology Instrumentation and Accessories
Subpart E—Immunology Laboratory Equipment and Reagents
Subpart E—Specimen Preparation Reagents
Subpart F—Automated and Semi-Automated Hematology Devices
Subpart F—Immunological Test Systems
DEP
Lambda, Peroxidase, Antigen, Antiserum, Control
DEY
Igm, Peroxidase, Antigen, Antiserum, Control
DFD
Kappa, Peroxidase, Antigen, Antiserum, Control
DGH
Igd, Peroxidase, Antigen, Antiserum, Control
DAA
Igg, Peroxidase, Antigen, Antiserum, Control
DGO
Ige, Peroxidase, Antigen, Antiserum, Control
DHF
D/Km-1, Antigen, Antiserum, Control
LYE
Cytokeratins
NUA
System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection
PFR
System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection
PFS
System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection
PKB
Autosomal Recessive Carrier Screening Gene Mutation Detection System
Subpart G—Tumor Associated Antigen immunological Test Systems
Subpart H—Hematology Kits and Packages
Subpart J—Products Used In Establishments That Manufacture Blood and Blood Products
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
PA
/
subpart-f—immunological-test-systems
/
PFR
View Source
System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection
Page Type
Product Code
MAUDE Alerts
View and Sign Up For MAUDE Alerts
Loading...