One Step Menopausal Test 210-01

GUDID B512210011

UNIVERSAL MEDITECH INC.

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

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• 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