RapID R4653047

GUDID 00848838072529

RapID STAPH PLUS QC Set/4

REMEL, INC.

Bacterial species differentiation disc IVD

• Primary Device ID: 00848838072529
• NIH Device Record Key: e570700e-9704-4362-ad20-d4080e5bc000
• Commercial Distribution Discontinuation: 2025-05-05
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: RapID
• Version Model Number: R4653047
• Catalog Number: R4653047
• 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: true
• 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	00848838072529 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2025-05-06
• Device Publish Date: 2022-12-23

Devices Manufactured by REMEL, INC.

• 00848838072529 - RapID: 2025-05-06RapID STAPH PLUS QC Set/4
• 00848838072529 - RapID: 2025-05-06 RapID STAPH PLUS QC Set/4
• 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