OvuSign® LH card OSH-143-35-01

GUDID 10743816000778

OvuSign® LH card; 35 Test Kit; CE

PRINCETON BIOMEDITECH CORPORATION

Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical

• Primary Device ID: 10743816000778
• NIH Device Record Key: 443c4c89-0cf3-4118-9b19-607263734835
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OvuSign® LH card
• Version Model Number: OSH-143-35-01
• Catalog Number: OSH-143-35-01
• Company DUNS: 362917692
• Company Name: PRINCETON BIOMEDITECH CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• 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

Customer Support Contacts

• Phone: 7322741000
• Email: info@pbmc.com
• Phone: 7322741000
• Email: info@pbmc.com
• Phone: 7322741000
• Email: info@pbmc.com
• Phone: 7322741000
• Email: info@pbmc.com
• Phone: 7322741000
• Email: info@pbmc.com
• Phone: 7322741000
• Email: info@pbmc.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10743816000778 [Primary]

FDA Product Code

• CEP: Radioimmunoassay, Luteinizing Hormone

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2022-06-10
• Device Publish Date: 2016-09-23

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