ACU-DTM

GUDID 00814105021200

ACU-DTM, Dermatophyte Test Medium, 24/bX

ACUDERM, INC.

Multiple dermatophyte species culture isolate identification IVD, kit Multiple dermatophyte species culture isolate identification IVD, kit Multiple dermatophyte species culture isolate identification IVD, kit Multiple dermatophyte species culture isolate identification IVD, kit Multiple dermatophyte species culture isolate identification IVD, kit Multiple dermatophyte species culture isolate identification IVD, kit Multiple dermatophyte species culture isolate identification IVD, kit Multiple dermatophyte species culture isolate identification IVD, kit Multiple dermatophyte species culture isolate identification IVD, kit Multiple dermatophyte species culture isolate identification IVD, kit Multiple dermatophyte species culture isolate identification IVD, kit Multiple dermatophyte species culture isolate identification IVD, kit Multiple dermatophyte species culture isolate identification IVD, kit 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