FDA.reportPublic FDA data

NA

Primary DI
04719872782193
Brand
NA
Company
PHARMIGENE, Inc.
Model
PG-0681A-024
Device description
The PG0681 Detection Reagent is used for detection of the CYP2C19*2 (c.681 G>A) SNP.
Published
2023-06-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MVUReagents, Specific, Analyte

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MVUReagents, Specific, AnalytePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719872782193PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719872782193047198727821934719872782193

GMDN Terms#

Term, Definition table
TermDefinition
Cytochrome P450 (CYP450) gene polymorphism IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used to evaluate a clinical specimen to diagnose or predict gene polymorphisms within the Cytochrome P450 superfamily (CYP450) that are associated with metabolism of xenobiotics/drugs, including warfarin, analgesics and/or anti-depressants.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-25 Degrees Celsius-15 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+886227985885service@pharmigene.com

Regulatory Flags#

DUNS number
658637223
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719872780014NAPG-IC01A-0242023-06-14
04719872780205NAPG-1502A-0242023-06-14
04719872780441NAPG-5801A-0242023-06-14
04719872780618NAPG-5701A-0242023-06-14
04719872780717NAPG-3101A-0242023-06-14
04719872780878NAPG-B27A-0242023-06-14
04719872781653NAPG-1639A-0242023-06-14
04719872781691NAPG-1075A-0242023-06-14
04719872781738NAPG-0430A-0242023-06-14
04719872782216NAPG-0636A-0242023-06-14
04719872782230NAPG-1301A-0242023-06-14
04719872782254NAPG-5101A-0242023-06-14
04719872782278NAPG-0602A-0242023-06-14

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