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- MiscellaneousMiscellaneous
- OYCPump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor3Product Code
- PQTAlpha-L-Iduronidase (Idua) Newborn Screening Test System2Product Code
- PQUAlpha-D-Glucosidase (Gaa) Newborn Screening Test System2Product Code
- PQVß-Glucocerebrosidase (Gba) Newborn Screening Test System2Product Code
- PQWAlpha-D-Galactosidase A (Gla) Newborn Screening Test System2Product Code
- OZOAutomated Insulin Dosing , Threshold Suspend3Product Code
- QCLAcid-Sphingomyelinase (Asm) Newborn Screening Test System2Product Code
- QCMß-Galactocerebrosidase (Galc) Newborn Screening Test System2Product Code
- QDHMenopause Test System2Product Code
- QEIBreast Milk Macronutrients Test System2Product Code
- QJEMuscular Dystrophy Newborn Screening Test2Product Code
- QDJDirect-To-Consumer Access Pharmacogenetic Assessment System2Product Code
- OZPAutomated Insulin Dosing Device System, Single Hormonal Control3Product Code
- LHEController, Closed-Loop Blood Glucose3Product Code
- LKVEnzyme Immunoassay, Fetal Fibronectin3Product Code
- LMYMonitor, Skin Resistance/Skin Temperature, For Insulin Reactions3Product Code
- LTCHyaline Membrane Disease Assay3Product Code
- MDSSensor, Glucose, Invasive3Product Code
- MWQSystem, Test, Total Antioxidant Status3Product Code
- NCTInstrument, Glucose, Noninvasive Technology3Product Code
- NQCTest, Breath Analysis, Volatile Organic CompoundsFProduct Code
- NUKFor Export Only - Antigen, Anti-Cardiac, Indirect Fluorescent Antibody Test SystemNProduct Code
- NULFor Export Only - Antigen, Anti-Skeletal, Indirect Fluorescent Antibody Test SystemNProduct Code
- OTVResearch Use Only/Clinical Chemistry DevicesNProduct Code
- OZQAutomated Insulin Dosing Device System, Bihormonal Control3Product Code
- PAQTest, Nr2 AntibodyNProduct Code
- PARTest, Volatile Organic Compounds Breath AnalysisFProduct Code
- PDAInvestigational Use Only - Clinical ChemistryNProduct Code
- PEJSalivary Estriol Test3Product Code
- PHKTest, Cell Mediated Immune Response, Liver And Small Bowel Transplant/TransplantationNProduct Code
- PQFSensor, Glucose, Invasive, Non-Adjunctive3Product Code
- PZESensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated3Product Code
- QCDContinuous Glucose Monitor, Implanted, Adjunctive Use3Product Code
- QHJSensor, Glucose, Implanted, Non-Adjunctive Use3Product Code
- QRVSetmelanotide Eligibility Gene Variant Detection System2Product Code
- QWZPrognostic Test For Assessment Of Chronic Kidney Disease Progression2Product Code
- QXCDiabetes Digital Therapeutic Device2Product Code
- SBAIntegrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate2Product Code
- SCHLdt, Approved By Nys ClepNProduct Code
- SCEIvd Offered As Ldt, First Marketed Before May 6, 2024, Not Modified Beyond Scope Described In Preamble To Ldt Final RuleNProduct Code
- SCFLdt, Unmet Need Within An Integrated Healthcare SystemNProduct Code
- SCGModified Version Of Another Manufacturer’S Fda-Authorized Test Within Scope Described In Preamble To Ldt Final RuleNProduct Code
- SCIIvd Offered As Ldt, Not An Ldt Or Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final RuleNProduct Code
- SCJLdt, Not Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final RuleNProduct Code
- Submissions with No Product CodeMiscellaneous
- Subpart B—Biological StainsCFR Sub-Part
- Subpart B—Clinical Chemistry Test SystemsCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- Subpart C—Microbiology DevicesCFR Sub-Part
- Subpart D—Clinical Toxicology Test SystemsCFR Sub-Part
- Subpart D—Pathology Instrumentation and AccessoriesCFR Sub-Part
- Subpart D—Serological ReagentsCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
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ß-Galactocerebrosidase (Galc) Newborn Screening Test System
- Page Type
- Product Code
- Definition
- For quantitative measurement of the activity of ß-galactocerebrosidase (GALC) from newborn dried blood spot specimens as an aid in screening newborns for Krabbe disease.
- Physical State
- Neonatal screening test, in vitro diagnostic device.
- Technical Method
- Quantitative enzymatic activity assay.
- Target Area
- Newborn dried blood spot specimens.
- Regulation Medical Specialty
- Chemistry
- Review Panel
- Chemistry
- Submission Type
- 510(K)
- Device Classification
- Class 2
- Regulation Number
- 862.1488
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Ineligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
No Linked CFR Text
Product code QCM is linked to regulation 21CFR862.1488, which does not seem to exist yet. It may be pending at the moment.