NeoPATH Pro Universal AP Polymer Kit

GUDID 00847627038951

BIOCARE MEDICAL LLC

Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry
Primary Device ID00847627038951
NIH Device Record Key8db0ffbd-84dd-42de-852a-11e1d6d72f7a
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeoPATH Pro Universal AP Polymer Kit
Version Model NumberNPRI10027KT135
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 Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100847627038951 [Primary]

FDA Product Code

PPMGeneral Purpose Reagent

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-02
Device Publish Date2025-05-23

Devices Manufactured by BIOCARE MEDICAL LLC

00847627027122 - BRAF V600E [VE1]2025-06-09
00847627035790 - TTF-1 [SPT24]2025-06-02
00847627038951 - NeoPATH Pro Universal AP Polymer Kit2025-06-02
00847627038951 - NeoPATH Pro Universal AP Polymer Kit2025-06-02
00847627036247 - Treponema pallidum (Spirochete)2025-05-26
00847627039620 - Arginase-12025-05-26
00847627040213 - CD3 T-Cell2025-05-15
00847627040466 - Helicobacter pylori [EPR10353]2025-04-28
00847627040473 - Helicobacter pylori [EPR10353]2025-04-28

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