URO-3 Triple Stain (CD44+p53) with CK20

GUDID 00847627011718

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 Immunohistochemistry antibody detection IVD, reagent Multiple bladder tissue/tumour marker IVD, antibody Multiple bladder tissue/tumour marker IVD, antibody Multiple bladder tissue/tumour marker IVD, antibody Multiple bladder tissue/tumour marker IVD, antibody Multiple bladder tissue/tumour marker IVD, antibody Multiple bladder tissue/tumour marker IVD, antibody Multiple bladder tissue/tumour marker IVD, antibody Multiple bladder tissue/tumour marker IVD, antibody Multiple bladder tissue/tumour marker IVD, antibody Multiple bladder tissue/tumour marker IVD, antibody Multiple bladder tissue/tumour marker IVD, antibody Multiple bladder tissue/tumour marker IVD, antibody Multiple bladder tissue/tumour marker IVD, antibody Multiple bladder tissue/tumour marker IVD, antibody Multiple bladder tissue/tumour marker IVD, antibody Multiple bladder tissue/tumour marker IVD, antibody Multiple bladder tissue/tumour marker IVD, antibody

• Primary Device ID: 00847627011718
• NIH Device Record Key: 121ab87f-c74a-4811-9e4f-e09458a649a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: URO-3 Triple Stain (CD44+p53) with CK20
• Version Model Number: PM370TSAA
• 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: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847627011718 [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: 2023-03-09
• Device Publish Date: 2023-03-01

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