OSOM BV Blue 25T Kit 183

GUDID 10742860100052

SEKISUI DIAGNOSTICS, LLC

Vaginal pH screening IVD, kit, rapid colorimetric, clinical

• Primary Device ID: 10742860100052
• NIH Device Record Key: 2b0687fc-41a3-4797-9b74-d61c4074f68b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OSOM BV Blue 25T Kit
• Version Model Number: 183
• Catalog Number: 183
• Company DUNS: 966812344
• Company Name: SEKISUI DIAGNOSTICS, LLC
• Device Count: 25
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00742860100055 [Primary]
GS1	10742860100052 [Unit of Use]

FDA Product Code

• MXB: Test, Vaginal, Bacterial Sialidase

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: 2026-01-06
• Device Publish Date: 2025-12-29

Devices Manufactured by SEKISUI DIAGNOSTICS, LLC

• 10742860100052 - OSOM BV Blue 25T Kit: 2026-01-06
• 10742860100052 - OSOM BV Blue 25T Kit: 2026-01-06
• 00742860100062 - OSOM BV Blue Control Kit: 2026-01-06
• 00742860000065 - OSOM Flu SARS-CoV-2 Combo Test: 2025-12-23 OSOM Flu SARS-CoV-2 Combo Test
• 10742860100663 - OSOM RSV Test Home: 2025-05-27 OSOM RSV Test
• 00628063401291 - Acetaminophen: 2023-05-16
• 00628063401307 - Acetaminophen Calibrator: 2023-05-16
• 00628063401314 - Alinity c Acetaminophen: 2023-05-16
• 00628063401321 - Alinity c Acetaminophen Calibrator: 2023-05-16