ACU-DTM

GUDID 00814105021200

ACU-DTM, Dermatophyte Test Medium, 24/bX

ACUDERM, INC.

Multiple dermatophyte species culture isolate identification IVD, kit

• Primary Device ID: 00814105021200
• NIH Device Record Key: 41973e76-38d1-4c38-bc48-63e932d00968
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACU-DTM
• Version Model Number: M101
• Company DUNS: 071426803
• Company Name: ACUDERM, INC.
• Device Count: 24
• 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: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	00814105021200 [Unit of Use]
GS1	10814105021207 [Primary]

FDA Product Code

• JSJ: Culture Media, 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: 2020-09-30
• Device Publish Date: 2020-09-22

On-Brand Devices [ACU-DTM]

• 00814105021217: ACU-DTM, Dermatophyte Test Medium, 24/bX
• 00814105021200: ACU-DTM, Dermatophyte Test Medium, 24/bX