FDA.reportPublic FDA data

Factor II Prothrombin G20210A Kit

Primary DI
04038377021591
Brand
Factor II Prothrombin G20210A Kit
Company
Roche Diagnostics GmbH
Model
1
Catalog number
04618955001
Published
2016-03-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
NPRTEST, FACTOR II G20210A MUTATIONS, GENOMIC DNA PCR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NPRTest, Factor Ii G20210a Mutations, Genomic Dna PcrHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038377021591PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038377021591040383770215914038377021591

GMDN Terms#

Term, Definition table
TermDefinition
Coagulation factor II (prothrombin) mutation IVD, kit, nucleic acid technique (NAT)A collection of reagents and other associated materials intended to be used to evaluate a clinical specimen to diagnose, monitor or predict the coagulation factor II (prothrombin) G20210A mutation associated with venous thrombosis, using a nucleic acid technique (NAT).

Regulatory Flags#

DUNS number
315028860
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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15420045506701INVADERHologic, Inc.NPR2016-08-29