Multichem AMH AM501X

GUDID 05391523441339

TECHNO-PATH MANUFACTURING LIMITED

Multiple-type clinical chemistry analyte profile IVD, control

• Primary Device ID: 05391523441339
• NIH Device Record Key: 88421a20-d3a5-4631-a9bd-350dce0bfaca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Multichem AMH
• Version Model Number: AM501X
• Catalog Number: AM501X
• Company DUNS: 896365983
• Company Name: TECHNO-PATH MANUFACTURING LIMITED
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05391523441339 [Primary]

FDA Product Code

• JJY: Multi-Analyte Controls, All Kinds (Assayed)

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: 2022-09-27
• Device Publish Date: 2022-09-19

On-Brand Devices [Multichem AMH]

• 05391523441384: AM503A
• 05391523441377: AM502A
• 05391523441360: AM501A
• 05391523441353: AM503X
• 05391523441346: AM502X
• 05391523441339: AM501X
• 05391523441322: AM500MA
• 05391523441315: AM500MX
• 05391523441209: AM500X
• 05391523441193: AM500A