HER-2 neu (RBT-HER2) BSB 2038 (ASR)

GUDID B502BSB2038ASR0

HER-2 neu is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5 (analyte specific reagent)

BIO SB, INC.

Assay development analyte-specific reagent IVD

• Primary Device ID: B502BSB2038ASR0
• NIH Device Record Key: dd649cb0-9c4d-4e6b-9d77-d5b58dae5a2d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HER-2 neu (RBT-HER2)
• Version Model Number: BSB 2038 (ASR)
• Catalog Number: BSB 2038 (ASR)
• Company DUNS: 102855447
• Company Name: BIO SB, INC.
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)561-1145
• Email: sales@biosb.com
• Phone: +1(800)561-1145
• Email: sales@biosb.com
• Phone: +1(800)561-1145
• Email: sales@biosb.com
• Phone: +1(800)561-1145
• Email: sales@biosb.com
• Phone: +1(800)561-1145
• Email: sales@biosb.com
• Phone: +1(800)561-1145
• Email: sales@biosb.com
• Phone: +1(800)561-1145
• Email: sales@biosb.com
• Phone: +1(800)561-1145
• Email: sales@biosb.com
• Phone: +1(800)561-1145
• Email: sales@biosb.com
• Phone: +1(800)561-1145
• Email: sales@biosb.com
• Phone: +1(800)561-1145
• Email: sales@biosb.com
• Phone: +1(800)561-1145
• Email: sales@biosb.com
• Phone: +1(800)561-1145
• Email: sales@biosb.com
• Phone: +1(800)561-1145
• Email: sales@biosb.com
• Phone: +1(800)561-1145
• Email: sales@biosb.com
• Phone: +1(800)561-1145
• Email: sales@biosb.com
• Phone: +1(800)561-1145
• Email: sales@biosb.com

Device Dimensions

• Total Volume: 0.1 Milliliter
• Total Volume: 0.1 Milliliter
• Total Volume: 0.1 Milliliter
• Total Volume: 0.1 Milliliter
• Total Volume: 0.1 Milliliter
• Total Volume: 0.1 Milliliter
• Total Volume: 0.1 Milliliter
• Total Volume: 0.1 Milliliter
• Total Volume: 0.1 Milliliter
• Total Volume: 0.1 Milliliter
• Total Volume: 0.1 Milliliter
• Total Volume: 0.1 Milliliter
• Total Volume: 0.1 Milliliter
• Total Volume: 0.1 Milliliter
• Total Volume: 0.1 Milliliter
• Total Volume: 0.1 Milliliter
• Total Volume: 0.1 Milliliter

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
HIBCC	B502BSB2038ASR0 [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: 2025-03-26
• Device Publish Date: 2025-03-18

On-Brand Devices [HER-2 neu (RBT-HER2)]

• B502BSB2040ASR0: HER-2 neu is a rabbit monoclonal antibody derived from cell culture supernatant that is concentr
• B502BSB2039ASR0: HER-2 neu is a rabbit monoclonal antibody derived from cell culture supernatant that is concentr
• B502BSB2038ASR0: HER-2 neu is a rabbit monoclonal antibody derived from cell culture supernatant that is concentr