FDA.reportPublic FDA data

NA

Primary DI
04719872780014
Brand
NA
Company
PHARMIGENE, Inc.
Model
PG-IC01A-024
Device description
The PGIC01 Detection Reagent is used for amplification of an internal control gene.
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
04719872780014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719872780014047198727800144719872780014

GMDN Terms#

Term, Definition table
TermDefinition
Killer cell immunoglobulin-like receptor (KIR) genotype/HLA ligand detection IVD, primerA defined piece of single-stranded nucleic acid which binds to and initiates replication of a target nucleic acid template in an assay intended to be used to evaluate a clinical specimen to diagnose, monitor or predict one or multiple polymorphisms associated with killer cell immunoglobulin-like receptors (KIR) and/or their HLA associated ligands. KIR genotypes detected may include but are not limited to KIR2DL4, KIR3DL2, and KIR3DP1, associated with immune responses e.g., graft versus host disease, autoimmune disease and acute organ rejection.

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
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
04719872782193NAPG-0681A-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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