Spectra™ Candida Agar

GUDID 00842558116709

REMEL, INC.

Differential/selective agar culture medium IVD

• Primary Device ID: 00842558116709
• NIH Device Record Key: cb9525eb-0e62-4c10-8f17-76e002f697c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spectra™ Candida Agar
• Version Model Number: R01833
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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	00842558116709 [Primary]

FDA Product Code

• JSI: Culture Media, Selective And 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: 2026-02-17
• Device Publish Date: 2026-02-09

Devices Manufactured by REMEL, INC.

• 00842558116709 - Spectra™ Candida Agar: 2026-02-17
• 00842558116709 - Spectra™ Candida Agar: 2026-02-17
• 00848838072772 - MicroTest M6: 2026-02-17 M6 (1.5ml) Universal Swab Kit PK/100
• 00848838074844 - MicroTest M4RT: 2026-02-17 M4RT(3ml) Universal Flock Swab Kit PK/100
• 00848838075018 - MicroTest M6: 2026-02-17 M6(1.5ml) Traditional FlockSwab KitPK/100
• 00848838091742 - VersaTREK™: 2026-02-04
• 00848838003158 - Strep Selective II Agar: 2026-01-26
• 00848838059865 - ^BM^ PK/50 OXIDASE TEST: 2026-01-26 ^BM^ PK/50 OXIDASE TEST
• 00842558116402 - BactiSwab Dry PK/100: 2025-06-27