Progesterone Receptor (PR) [SP2]

GUDID 00847627001641

BIOCARE MEDICAL LLC

Estrogen (oestrogen)/progesterone receptor IVD, antibody

• Primary Device ID: 00847627001641
• NIH Device Record Key: 188afc39-f66b-421b-a602-4cc2a3b648fb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Progesterone Receptor (PR) [SP2]
• Version Model Number: ACI302A
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847627001641 [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: 2022-12-15
• Device Publish Date: 2022-12-07

On-Brand Devices [Progesterone Receptor (PR) [SP2]]

• 00847627002112: API302AA
• 00847627001658: ACI302C
• 00847627001641: ACI302A
• 00847627001986: APA302AA