Device
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. Th...
Manufacturer
Entrogen, Inc.
Entrogen, Inc.
Model: CRCDX-RAS
Catalog: CRCDX-RAS
DI: 05060536830569
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-06
Current Version: 2026-05-14
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.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
40aa2dce-203c-4f0f-8a33-2974d4574188
Distribution Status:
In Commercial Distribution
DUNS Number:
014009566
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
Yes
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
05060536830569
Type:
Primary
Issuing Agency:
GS1
GMDN
Code:
Name:
FDA Product Codes
None
Environmental Conditions
Storage Handling - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling Low - @attributes - Value:
-40
Storage Handling - Storage Handling High - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling High - @attributes - Value:
-10
Storage Handling - Storage Handling Type:
Storage Environment Temperature