RISH™ RNA Negative Control Probe

GUDID 00847627035677

BIOCARE MEDICAL LLC

Nucleic acid hybridization detection IVD, control Nucleic acid hybridization detection IVD, control Nucleic acid hybridization detection IVD, control Nucleic acid hybridization detection IVD, control Nucleic acid hybridization detection IVD, control Nucleic acid hybridization detection IVD, control Nucleic acid hybridization detection IVD, control Nucleic acid hybridization detection IVD, control Nucleic acid hybridization detection IVD, control Nucleic acid hybridization detection IVD, control Nucleic acid hybridization detection IVD, control Nucleic acid hybridization detection IVD, control Nucleic acid hybridization detection IVD, control Nucleic acid hybridization detection IVD, control Nucleic acid hybridization detection IVD, control Nucleic acid hybridization detection IVD, control Nucleic acid hybridization detection IVD, control

• Primary Device ID: 00847627035677
• NIH Device Record Key: 4058d8dd-e16a-4388-88e9-07bd4f927e9b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RISH™ RNA Negative Control Probe
• Version Model Number: OPPA4029T60
• 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: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847627035677 [Primary]

FDA Product Code

• MVU: Reagents, Specific, Analyte

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: 2024-06-07
• Device Publish Date: 2024-05-30

Devices Manufactured by BIOCARE MEDICAL LLC

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• 00847627035677 - RISH™ RNA Negative Control Probe: 2024-06-07
• 00847627035677 - RISH™ RNA Negative Control Probe: 2024-06-07
• 00847627035851 - Helicobacter pylori [EPR10353]: 2024-05-31
• 00847627033604 - intelliPATH MAX: 2024-05-08
• 00847627033666 - intelliPATH MAX: 2024-05-08
• 00847627035202 - INSM1 [BLR272L]: 2024-04-09
• 00847627035158 - INSM1 [BLR272L]: 2024-03-20
• 00847627035165 - INSM1 [BLR272L]: 2024-03-20