Cytomegalovirus (CMV)

GUDID 00847627035400

BIOCARE MEDICAL LLC

Cytomegalovirus (CMV) antigen IVD, antibody

• Primary Device ID: 00847627035400
• NIH Device Record Key: 45842db0-be65-4d42-9f89-d1001e7fbdf2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cytomegalovirus (CMV)
• Version Model Number: AVA118G
• 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 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	00847627035400 [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: 2023-12-12
• Device Publish Date: 2023-12-04

Devices Manufactured by BIOCARE MEDICAL LLC

• 00847627036667 - MACH 2 Universal HRP Polymer Detection: 2024-12-16
• 00847627035547 - TLE 1 [EPR9386(2)]: 2024-11-25
• 00847627035554 - TLE 1 [EPR9386(2)]: 2024-11-25
• 00847627035561 - TLE 1 [EPR9386(2)]: 2024-11-25
• 00847627035585 - TLE 1 [EPR9386(2)]: 2024-11-25
• 00847627035592 - TLE 1 [EPR9386(2)]: 2024-11-25
• 00847627034939 - Kappa (M) + Lambda (P): 2024-08-28
• 00847627036568 - Helicobacter pylori [EPR10353]: 2024-08-23