SIGNAL BLOOD CULTURE SYSTEM 1 X 20

GUDID 05032384013623

OXOID LIMITED

Blood culture broth kit IVD

• Primary Device ID: 05032384013623
• NIH Device Record Key: 1ff10dad-0613-4232-9f37-59c6e728442a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SIGNAL BLOOD CULTURE SYSTEM 1 X 20
• Version Model Number: BC0100M
• Company DUNS: 365355452
• Company Name: OXOID LIMITED
• Device Count: 1
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05032384013623 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K862946

FDA Product Code

• JSG: Culture Media, Non-Selective And Non-Differential

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: 2022-12-12
• Device Publish Date: 2022-12-04

Devices Manufactured by OXOID LIMITED

• 05032384003914 - SELENITE CYST.BROTH BASE: 2025-07-31
• 05032384126453 - PEPTONE WATER (ANDRADE): 2025-07-07
• 05032384127993 - REAGENT SPOT INDOLE DMACA: 2025-07-07
• 05032384502974 - IMAGEN Parainfluenza Virus Types 1, 2 and 3: 2025-01-07
• 05032384502981 - IMAGEN Influenza Virus A and B: 2025-01-07
• 05032384082919 - ORSAB SELECTIVE SUPPLEMENT: 2024-11-06
• 05032384083237 - OXACILLIN RES. SCREENING AGAR BASE: 2024-11-06
• 05032384128006 - Microbact Staph 12S: 2024-11-05