AccessGUDID - DEVICE: Dako ER/PR pharmDx Kit (Link) (05700571104897)

GUDID

Device Identifier (DI) Information

Brand Name: Dako ER/PR pharmDx Kit (Link)
Version or Model: SK310
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: AGILENT TECHNOLOGIES, INC.

Primary DI Number: 05700571104897
Issuing Agency: GS1
Commercial Distribution End Date: September 30, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 084963177 *Terms of Use

Device Description: Dako ER/PR pharmDx Kit (Link)

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?
57209	Estrogen (oestrogen)/progesterone receptor IVD, kit, enzyme immunohistochemistry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of estrogen (oestrogen) and/or progesterone receptors in a clinical specimen, using an enzyme immunohistochemistry method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MXZ	Immunohistochemistry assay,antibody,progesterone receptor
MYA	IMMUNOHISTOCHEMISTRY ANTIBODY ASSAY, ESTROGEN RECEPTOR

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K042884	000

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

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 50 Tests

Device Record Status

Public Device Record Key: 32045867-5820-43a8-9bd9-1e7ab3066a86
Public Version Date: September 06, 2023
Public Version Number: 9
DI Record Publish Date: September 16, 2016