IgM control slides BSB 3687

GUDID B502BSB36870

IgM Control

BIO SB, INC.

Total immunoglobulin M (IgM total) IVD, control

• Primary Device ID: B502BSB36870
• NIH Device Record Key: efa15a60-c7df-4c19-8c2e-a20cd88a74e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IgM control slides
• Version Model Number: Control Slides, 5
• Catalog Number: BSB 3687
• Company DUNS: 102855447
• Company Name: BIO SB, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B502BSB36870 [Primary]

FDA Product Code

• LJG: Quality Control Slides

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2025-03-04
• Device Publish Date: 2020-06-30

On-Brand Devices [IgM control slides]

• L502BSB5686: IgM, control
• L502BSB3687: IgM Control
• B502BSB56860: IgM, control
• B502BSB36870: IgM Control
• B502BSB9238CS0: IgM Control Slides