OSOM BV Blue Control Kit 184

GUDID 00742860100062

SEKISUI DIAGNOSTICS, LLC

Multiple vaginitis/vaginosis-associated pathogen nucleic acid IVD, control

• Primary Device ID: 00742860100062
• NIH Device Record Key: 71ef780d-7fb2-42aa-93dd-7311ee9e8d6e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OSOM BV Blue Control Kit
• Version Model Number: 184
• Catalog Number: 184
• Company DUNS: 966812344
• Company Name: SEKISUI DIAGNOSTICS, 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: 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00742860100062 [Primary]

FDA Product Code

• JTR: Kit, Quality Control For Culture Media

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

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• 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