Estrogen Receptor, Ready to use IHC (Quanto)

GUDID 00673693559096

RICHARD-ALLAN SCIENTIFIC COMPANY

Estrogen (oestrogen)/progesterone receptor IVD, kit, enzyme immunohistochemistry Estrogen (oestrogen)/progesterone receptor IVD, kit, enzyme immunohistochemistry
Primary Device ID00673693559096
NIH Device Record Key7022eff9-5598-4f67-87e5-ecd5899728a3
Commercial Distribution StatusIn Commercial Distribution
Brand NameEstrogen Receptor, Ready to use IHC (Quanto)
Version Model NumberRM-9101-RQ
Company DUNS929504710
Company NameRICHARD-ALLAN SCIENTIFIC COMPANY
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 Usetrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100673693559096 [Primary]

FDA Product Code

MYAImmunohistochemistry Antibody Assay, Estrogen Receptor

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-21

Devices Manufactured by RICHARD-ALLAN SCIENTIFIC COMPANY

00673693658454 - Epredia2023-08-22 Estrogen Receptor [1D5] ASR.
00673693658492 - Epredia2023-08-22 ER (Cocktail) [1D5+6F11] ASR
00673693658508 - Epredia2023-08-22 ER (Cocktail) [1D5+6F11] ASR
00673693658515 - Epredia2023-08-22 ER (Cocktail) [1D5+6F11] ASR.
00673693658522 - Epredia2023-08-22 ER (Cocktail) [1D5+6F11] ASR
00673693658942 - Epredia2023-08-22 Progesterone Recept. [YR85] ASR
00673693658959 - Epredia2023-08-22 Progesterone Recept. [YR85] ASR
00673693658409 - Epredia2023-08-10
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