ACT II Dual Transport PK/10

GUDID 00842558116433

REMEL, INC.

General specimen collection kit IVD, clinical

• Primary Device ID: 00842558116433
• NIH Device Record Key: 7e3792c3-813d-4de4-b3bc-e529a2a869b7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACT II Dual Transport PK/10
• Version Model Number: R124102
• Company DUNS: 065769564
• Company Name: REMEL, INC.
• 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	00842558116433 [Primary]

FDA Product Code

• JSL: Culture Media, Anaerobic Transport

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: 2024-08-14
• Device Publish Date: 2024-08-06

Devices Manufactured by REMEL, INC.

• 00848838023156 - REMEL: 2025-04-02 Anaer Nitrate Reagent A BTL/25ml
• 00848838023194 - REMEL: 2025-04-02 Bile Solubility Reagent (2%) BTL/25ml
• 00848838023200 - REMEL: 2025-04-02 Anaer Nitrate Reagent B BTL/25ml
• 00848838023385 - REMEL: 2025-04-02 Nitrate Reagent A for AFB BTL/25ml
• 00848838023392 - REMEL: 2025-04-02 Nitrate Reagent B for AFB BTL/25ml
• 00848838023606 - REMEL: 2025-04-02 PS80 Hydrolysis Substrate Conc VL/5ml
• 00848838031205 - REMEL: 2025-04-02 Malachite Green (5%) BTL/250ml
• 00848838009990 - REMEL: 2025-03-28 Thio Med w/Dex,Hemin,Vit K (5ml) 20/PK