FLEX Mono Mo A-Hu Progesterone Receptor Clone PgR 636 RTU (Link)

GUDID 05700571101759

FLEX Monoclonal Mouse Anti-Human Progesterone Receptor Clone PgR 636 Ready-to-Use (Link)

Dako North America, Inc.

Estrogen (oestrogen)/progesterone receptor IVD, antibody Estrogen (oestrogen)/progesterone receptor IVD, antibody Estrogen (oestrogen)/progesterone receptor IVD, antibody Estrogen (oestrogen)/progesterone receptor IVD, antibody Estrogen (oestrogen)/progesterone receptor IVD, antibody Estrogen (oestrogen)/progesterone receptor IVD, antibody Estrogen (oestrogen)/progesterone receptor IVD, antibody Estrogen (oestrogen)/progesterone receptor IVD, antibody Estrogen (oestrogen)/progesterone receptor IVD, antibody Estrogen (oestrogen)/progesterone receptor IVD, antibody Estrogen (oestrogen)/progesterone receptor IVD, antibody Estrogen (oestrogen)/progesterone receptor IVD, antibody Estrogen (oestrogen)/progesterone receptor IVD, antibody Estrogen (oestrogen)/progesterone receptor IVD, antibody Estrogen (oestrogen)/progesterone receptor IVD, antibody Estrogen (oestrogen)/progesterone receptor IVD, antibody Estrogen (oestrogen)/progesterone receptor IVD, antibody Estrogen (oestrogen)/progesterone receptor IVD, antibody Estrogen (oestrogen)/progesterone receptor IVD, antibody Estrogen (oestrogen)/progesterone receptor IVD, antibody
Primary Device ID05700571101759
NIH Device Record Key17df6b07-deaf-4284-b05d-b78784ab4951
Commercial Distribution StatusIn Commercial Distribution
Brand NameFLEX Mono Mo A-Hu Progesterone Receptor Clone PgR 636 RTU (Link)
Version Model NumberIR068
Company DUNS099999732
Company NameDako North America, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1-805-566-6655
Emaildako.usregulatory@agilent.com
Phone+1-805-566-6655
Emaildako.usregulatory@agilent.com
Phone+1-805-566-6655
Emaildako.usregulatory@agilent.com
Phone+1-805-566-6655
Emaildako.usregulatory@agilent.com
Phone+1-805-566-6655
Emaildako.usregulatory@agilent.com
Phone+1-805-566-6655
Emaildako.usregulatory@agilent.com
Phone+1-805-566-6655
Emaildako.usregulatory@agilent.com
Phone+1-805-566-6655
Emaildako.usregulatory@agilent.com
Phone+1-805-566-6655
Emaildako.usregulatory@agilent.com
Phone+1-805-566-6655
Emaildako.usregulatory@agilent.com
Phone+1-805-566-6655
Emaildako.usregulatory@agilent.com
Phone+1-805-566-6655
Emaildako.usregulatory@agilent.com
Phone+1-805-566-6655
Emaildako.usregulatory@agilent.com
Phone+1-805-566-6655
Emaildako.usregulatory@agilent.com
Phone+1-805-566-6655
Emaildako.usregulatory@agilent.com
Phone+1-805-566-6655
Emaildako.usregulatory@agilent.com
Phone+1-805-566-6655
Emaildako.usregulatory@agilent.com
Phone+1-805-566-6655
Emaildako.usregulatory@agilent.com
Phone+1-805-566-6655
Emaildako.usregulatory@agilent.com
Phone+1-805-566-6655
Emaildako.usregulatory@agilent.com

Device Dimensions

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Device Size Text, specify0
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Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105700571101759 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MXZImmunohistochemistry assay,antibody,progesterone receptor

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-06-24
Device Publish Date2017-01-03

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