Rubens Eosin-Phloxine

GUDID 00847627014443

BIOCARE MEDICAL LLC

Biological stain IVD Biological stain IVD Biological stain IVD Biological stain IVD
Primary Device ID00847627014443
NIH Device Record Key90f289f6-b470-46ba-9d49-76f224b18181
Commercial Distribution StatusIn Commercial Distribution
Brand NameRubens Eosin-Phloxine
Version Model NumberHTEP-GL
Company DUNS806617825
Company NameBIOCARE MEDICAL LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100847627014443 [Primary]

FDA Product Code

HYBEosin Y

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-15
Device Publish Date2022-12-07

Devices Manufactured by BIOCARE MEDICAL LLC

00847627035202 - INSM1 [BLR272L] 2024-04-09
00847627035158 - INSM1 [BLR272L]2024-03-20
00847627035165 - INSM1 [BLR272L] 2024-03-20
00847627035172 - INSM1 [BLR272L] 2024-03-20
00847627035189 - INSM1 [BLR272L] 2024-03-20
00847627035196 - INSM1 [BLR272L]2024-03-20
00847627035448 - PTEN (Tumor Suppressor)2024-02-20
00847627035462 - MCM2 + TOP2A2024-02-16

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