One Step Menopausal Test 210-01

GUDID B512210011

UNIVERSAL MEDITECH INC.

Follicle stimulating hormone (FSH) IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: B512210011
• NIH Device Record Key: 74070bd8-d139-41fb-a3ee-f5a9887834de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: One Step Menopausal Test
• Version Model Number: 21001
• Catalog Number: 210-01
• Company DUNS: 080243910
• Company Name: UNIVERSAL MEDITECH 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: 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: true

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B512210011 [Primary]

FDA Product Code

• CGJ: Radioimmunoassay, Follicle-Stimulating Hormone

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: 2021-10-25
• Device Publish Date: 2021-10-15

Devices Manufactured by UNIVERSAL MEDITECH INC.

• B512100011 - One Step Pregnancy Test: 2021-10-25
• B512200011 - One Step Ovulation Test: 2021-10-25
• B512210011 - One Step Menopausal Test: 2021-10-25
• B512210011 - One Step Menopausal Test: 2021-10-25
• 00860002273006 - DoublecheQ Pregnancy Test: 2019-08-09 The DoublecheQ Pregnancy Test is designed to be used for a qualitative determination of elevated human chorionic gonadotropin in
• 00680243766491 - DoublecheQ Pregnancy Test: 2019-06-28 The DoublecheQ Pregnancy Test is designed to be used for a qualitative determination of elevated human chorionic gonadotropin in