CorDx Tyfast

GUDID 00850042559871

CorDx Tyfast Ovulation Test Midstream

CORETESTS, INC.

Luteinizing hormone (LH) IVD, kit, rapid ICT, self-testing

• Primary Device ID: 00850042559871
• NIH Device Record Key: f07638f2-478d-4c67-b98a-0bb22248b324
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CorDx Tyfast
• Version Model Number: ACT21011-7
• Company DUNS: 036440919
• Company Name: CORETESTS, 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: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850042559871 [Primary]
GS1	10850042559878 [Package]; Package: [7 Units]; In Commercial Distribution

FDA Product Code

• NGE: Test, Luteinizing Hormone (Lh), Over The Counter

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: 2025-03-17
• Device Publish Date: 2025-03-07

On-Brand Devices [CorDx Tyfast ]

• 10850042559656: CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid Test POC
• 00850042559635: CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid Test POC
• 10850042559564: CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test OTC
• 10850042559557: CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test OTC
• 10850042559533: CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test OTC
• 00850042559529: CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test OTC
• 10850042559915: CorDx Tyfast COVID-19 Ag Rapid Test 4 tests/box
• 00850042559642: CorDx Tyfast COVID-19 Ag Rapid Test
• 00850042559888: CorDx Tyfast Ovulation Test Cassette
• 00850042559871: CorDx Tyfast Ovulation Test Midstream
• 10850042559830: CorDx Tyfast Pregnancy Test Cassette
• 10850042559823: CorDx Tyfast Pregnancy Test Cassette
• 00850042559819: CorDx Tyfast Pregnancy Test Cassette
• 10850042559779: CorDx Tyfast Ovulation Test Strip + Pregnancy Test Strip
• 10850042559762: CorDx Tyfast Pregnancy Test Midstream