HMB45 + MART-1 + Tyrosinase

GUDID 00847627034533

BIOCARE MEDICAL LLC

Immunohistochemistry antibody detection IVD, reagent Immunohistochemistry antibody detection IVD, reagent Immunohistochemistry antibody detection IVD, reagent Immunohistochemistry antibody detection IVD, reagent Immunohistochemistry antibody detection IVD, reagent Immunohistochemistry antibody detection IVD, reagent Immunohistochemistry antibody detection IVD, reagent Immunohistochemistry antibody detection IVD, reagent Immunohistochemistry antibody detection IVD, reagent Immunohistochemistry antibody detection IVD, reagent Immunohistochemistry antibody detection IVD, reagent Immunohistochemistry antibody detection IVD, reagent Immunohistochemistry antibody detection IVD, reagent Immunohistochemistry antibody detection IVD, reagent Immunohistochemistry antibody detection IVD, reagent Immunohistochemistry antibody detection IVD, reagent Immunohistochemistry antibody detection IVD, reagent
Primary Device ID00847627034533
NIH Device Record Keycedcf9fb-3bf3-4800-8a95-e16c33da8d80
Commercial Distribution StatusIn Commercial Distribution
Brand NameHMB45 + MART-1 + Tyrosinase
Version Model NumberALI165G7
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 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
GS100847627034533 [Primary]

FDA Product Code

NJTImmunohistochemistry Reagents And Kits

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-03-03
Device Publish Date2023-02-23

On-Brand Devices [HMB45 + MART-1 + Tyrosinase]

00847627031808OPAI165T60
00847627011251PM165H
00847627011244PM165AA
00847627008886IPI165G10
00847627006622CM165C
00847627006615CM165B
00847627034533ALI165G7

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