CRCdx® RAS Mutation Detection Kit

Primary DI
05060536830569
Brand
CRCdx® RAS Mutation Detection Kit
Company
Entrogen, Inc.
Model
CRCDX-RAS
Catalog number
CRCDX-RAS
Device description
CRCdx® RAS Detection Kit a qualitative real-time PCR in vitro diagnostic test 35 variants of extracted from formalin-fixed, paraffin-embedded (FFPE) cancer (CRC) tissue samples. The test is intended as a companion diagnostic (CDx) to aid in the identification of colorectal cancer (CRC) patients who may benefit from treatment with in accordance with the approved therapeutic product.
Published
2026-05-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060536830569PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060536830569050605368305695060536830569

GMDN Terms#

Term, Definition table
TermDefinition
KRAS gene mutation IVD, kit, nucleic acid technique (NAT)A collection of reagents and other associated materials intended to be used for the qualitative detection of the KRAS (v-ki-ras2 kirsten rat sarcoma viral oncogene homolog) mutation status and/or to evaluate a clinical specimen to predict or monitor the response to treatment with epidermal growth factor receptor (EGFR) inhibitors by determining the KRAS mutation status of tumour tissue using a nucleic acid technique (NAT).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-40 Degrees Celsius-10 Degrees Celsius

Regulatory Flags#

DUNS number
014009566
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true