DEVICE: Dako (05700571104354)

Download: XML | JSON

Device Identifier (DI) Information

Dako
K4071

Dako North America, Inc.
05700571104354
GS1
1
Dako ER/PR pharmDx Kit For the Dako Autostainer
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
Yes
No
No

GMDN

[?]

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, 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.
CLOSE

FDA Product Code

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

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: 50 Tests
CLOSE

Device Status

In Commercial Distribution
September 16, 2016

CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1-805-566-6655
dako.usregulatory@agilent.com
CLOSE