AccessGUDID - DEVICE: Dako (05700571106907)

GUDID

Device Identifier (DI) Information

Brand Name: Dako
Version or Model: IR084
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Dako North America, Inc.

Primary DI Number: 05700571106907
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 099999732 *Terms of Use

Device Description: FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a Clone EP1 Ready-to-Use (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:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Estrogen (oestrogen)/progesterone receptor IVD, antibody	One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of estrogen (oestrogen) and/or progesterone receptors in a clinical specimen.

FDA Product Code

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Product Code	Product Code Name
MYA	IMMUNOHISTOCHEMISTRY ANTIBODY ASSAY, ESTROGEN RECEPTOR

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K120663	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: 40-60 Tests

Device Record Status

Public Device Record Key: 447ce70e-fd24-4ca5-8993-f08a7cd7ae8d
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 16, 2016