Mono Mo A-Hu Progesterone Receptor, Cl PgR 636

GUDID 05700571102305

Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636

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 ID05700571102305
NIH Device Record Key54cb49fe-9de4-4bf7-a3a8-35a91f7e8be4
Commercial Distribution StatusIn Commercial Distribution
Brand NameMono Mo A-Hu Progesterone Receptor, Cl PgR 636
Version Model NumberM3569
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

Total Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter

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
GS105700571102305 [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 Date2016-09-16

On-Brand Devices [Mono Mo A-Hu Progesterone Receptor, Cl PgR 636]

05700571102305Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636
05700571102299Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636
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