MSH2

GUDID 00847627037565

BIOCARE MEDICAL LLC

MSH2 antigen IVD, antibody

• Primary Device ID: 00847627037565
• NIH Device Record Key: 9297a9cd-a1ba-43b2-a73b-68622afea61a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MSH2
• Version Model Number: NPAI219T80
• 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: false
• 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: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847627037565 [Primary]

FDA Product Code

• NJT: Immunohistochemistry Reagents And Kits

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: 2025-06-30
• Device Publish Date: 2025-06-20

On-Brand Devices [MSH2]

• 00847627031815: OPAI219T60
• 00847627026958: ALI219G7
• 00847627014108: PM219H
• 00847627011367: PM219AA
• 00847627006851: CM219CK
• 00847627006844: CM219BK
• 00847627006837: CM219AK
• 00847627004918: AVI219G
• 00847627037565: NPAI219T80
• 00847627037558: NPAI219T40