CK HMW [34BetaE12]

GUDID 00847627033321

Alternate name : Cytokeratin HMW [34BetaE12]

BIOCARE MEDICAL LLC

Cytokeratin IVD, antibody Cytokeratin IVD, antibody Cytokeratin IVD, antibody Cytokeratin IVD, antibody Cytokeratin IVD, antibody Cytokeratin IVD, antibody Cytokeratin IVD, antibody Cytokeratin IVD, antibody Cytokeratin IVD, antibody Cytokeratin IVD, antibody Cytokeratin IVD, antibody Cytokeratin IVD, antibody Cytokeratin IVD, antibody Cytokeratin IVD, antibody Cytokeratin IVD, antibody Cytokeratin IVD, antibody Cytokeratin IVD, antibody Cytokeratin IVD, antibody
Primary Device ID00847627033321
NIH Device Record Key280d8222-f739-4016-bb68-72da16bcec40
Commercial Distribution StatusIn Commercial Distribution
Brand NameCK HMW [34BetaE12]
Version Model NumberALI127G7
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 Perscriptionfalse
OTC Over-The-Counterfalse

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100847627033321 [Primary]

FDA Product Code

NJTImmunohistochemistry Reagents And Kits

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-02-13
Device Publish Date2023-01-18

On-Brand Devices [CK HMW [34BetaE12]]

00847627024862AVI127G
00847627011107PM127H
00847627011091PM127AA
00847627006288CM127C
00847627006271CM127A
00847627033321Alternate name : Cytokeratin HMW [34BetaE12]

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