AccessGUDID - DEVICE: HercepTest™ for the Dako Autostainer (05700572031994)

GUDID

Device Identifier (DI) Information

Brand Name: HercepTest™ for the Dako Autostainer
Version or Model: K5207
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: AGILENT TECHNOLOGIES SINGAPORE PTE LTD

Primary DI Number: 05700572031994
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 894671143 *Terms of Use

Device Description: HercepTest for the Dako Autostainer

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
43270	C-erbB2/Her2/neu oncoprotein IVD, kit, enzyme immunohistochemistry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of c-erbB2 oncoprotein, also known as Her2 or neu oncoprotein, in a clinical specimen using an enzyme immunohistochemistry method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MVC	System, Test, Her-2/Neu, Ihc

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius
Special Storage Condition, Specify: Fragile

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 50 Tests

Device Record Status

Public Device Record Key: d58678d3-2469-46a9-b4e6-7f22e757157b
Public Version Date: December 07, 2020
Public Version Number: 6
DI Record Publish Date: September 15, 2014