^BM^ PK/50 OXIDASE TEST

GUDID 00848838059865

^BM^ PK/50 OXIDASE TEST

REMEL, INC.

Bacterial species differentiation disc IVD

• Primary Device ID: 00848838059865
• NIH Device Record Key: 5916b262-69bb-4808-84e4-00cd26024ea8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ^BM^ PK/50 OXIDASE TEST
• Version Model Number: R9055635
• Company DUNS: 065769564
• Company Name: REMEL, 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848838059865 [Primary]

FDA Product Code

• JTO: Discs, Strips And Reagents, Microorganism Differentiation

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: 2026-01-26
• Device Publish Date: 2026-01-16

Devices Manufactured by REMEL, INC.

• 00848838003158 - Strep Selective II Agar: 2026-01-26
• 00848838059865 - ^BM^ PK/50 OXIDASE TEST: 2026-01-26^BM^ PK/50 OXIDASE TEST
• 00848838059865 - ^BM^ PK/50 OXIDASE TEST: 2026-01-26 ^BM^ PK/50 OXIDASE TEST
• 00842558116402 - BactiSwab Dry PK/100: 2025-06-27
• 00848838066665 - Amies Clear Gel,Single Swab PK/500: 2025-06-26
• 00848838066672 - Amies Clear Gel,Single Swab PK/50: 2025-06-26
• 00848838066689 - Amies Clear Gel,Dual Swab PK/500: 2025-06-26
• 00848838066696 - Amies Clear Gel,Dual Swab PK/50: 2025-06-26
• 00848838066702 - Amies Clear Gel,Wire Shaft Swab PK/100: 2025-06-26