Estrogen Receptor (ER) [SP1]

GUDID 00847627001627

BIOCARE MEDICAL LLC

Estrogen (oestrogen)/progesterone receptor IVD, antibody

• Primary Device ID: 00847627001627
• NIH Device Record Key: 4d33cfa3-3bab-4248-b233-7144a62b60f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Estrogen Receptor (ER) [SP1]
• Version Model Number: ACI301B
• 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	00847627001627 [Primary]

FDA Product Code

• MYA: Immunohistochemistry Antibody Assay, Estrogen Receptor

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 [Estrogen Receptor (ER) [SP1]]

• 00847627029164: APA301H
• 00847627024602: OPAA301T60
• 00847627002105: API301AA
• 00847627001955: APA301AA
• 00847627001634: ACI301C
• 00847627001627: ACI301B
• 00847627001610: ACI301A
• 00847627001412: ACA301A
• 00847627039026: NPAA301T80
• 00847627039019: NPAA301T40