NeoPATH Pro Universal AP Plus Polymer Kit

GUDID 00847627043047

BIOCARE MEDICAL LLC

Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry

• Primary Device ID: 00847627043047
• NIH Device Record Key: a5d82c6a-9c57-4837-a58e-28705c3f3fab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeoPATH Pro Universal AP Plus Polymer Kit
• Version Model Number: NPRI10101KT135
• Company DUNS: 806617825
• Company Name: BIOCARE MEDICAL LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847627043047 [Primary]

FDA Product Code

• PPM: General Purpose Reagent

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-06
• Device Publish Date: 2026-01-29

Devices Manufactured by BIOCARE MEDICAL LLC

• 00847627042279 - CK7: 2026-02-06
• 00847627043023 - NeoPATH Pro Rabbit Amp AP Plus Kit: 2026-02-06
• 00847627043047 - NeoPATH Pro Universal AP Plus Polymer Kit: 2026-02-06
• 00847627043047 - NeoPATH Pro Universal AP Plus Polymer Kit: 2026-02-06
• 00847627043061 - NeoPATH Pro Antigen Retrieval 1 (AR1): 2026-02-06
• 00847627042033 - Desmin: 2026-01-21
• 00847627042835 - CD19: 2026-01-21
• 00847627041937 - Myeloperoxidase (P): 2026-01-14
• 00847627042514 - Vimentin: 2026-01-14