GoldN Easy to Use FSH Test GN011ST

GUDID 00850059915370

The GoldN™ Easy to Use FSH Test is a rapid immunochromatographic assay for the qualitative detection of follicle-stimulating hormone (FSH) in urine to aid women in the assessment of the onset of menopause.

NOVODX Corporation

Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing

• Primary Device ID: 00850059915370
• NIH Device Record Key: 114f261a-6bb5-49f0-bac9-97726bc940e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GoldN Easy to Use FSH Test
• Version Model Number: GN011ST02-US
• Catalog Number: GN011ST
• Company DUNS: 119046376
• Company Name: NOVODX Corporation
• 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: true
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: true

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Fahrenheit and 30 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Fahrenheit and 30 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Fahrenheit and 30 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Fahrenheit and 30 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Fahrenheit and 30 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Fahrenheit and 30 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Fahrenheit and 30 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Fahrenheit and 30 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Fahrenheit and 30 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Fahrenheit and 30 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Fahrenheit and 30 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Fahrenheit and 30 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Fahrenheit and 30 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Fahrenheit and 30 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Fahrenheit and 30 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Fahrenheit and 30 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850059915370 [Primary]

FDA Product Code

• NGA: Test, Follicle Stimulating Hormone (Fsh), 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: 2025-02-03
• Device Publish Date: 2025-01-24

Devices Manufactured by NOVODX Corporation

• 00850059915370 - GoldN Easy to Use FSH Test: 2025-02-03The GoldN™ Easy to Use FSH Test is a rapid immunochromatographic assay for the qualitative detection of follicle-stimulating hormone (FSH) in urine to aid women in the assessment of the onset of menopause.
• 00850059915370 - GoldN Easy to Use FSH Test: 2025-02-03 The GoldN™ Easy to Use FSH Test is a rapid immunochromatographic assay for the qualitative detection of follicle-stimulating h
• 00850059915882 - GoldN Easy to Use Vaginal pH Test: 2025-01-20 The GoldN™ Easy to Use Vaginal pH Test is a fast pH value test of vaginal fluid specimens. The test is semi-quantitative for d
• 00850059915639 - GoldN Easy to Use Pregnancy Test: 2025-01-15 The GoldNTM Easy to Use Pregnancy Test is a rapid, visual immunoassay for the qualitative detection of human chorionic gonadotro
• 00850059915646 - GoldN Easy to Use Ovulation Test: 2024-10-04 The GoldNTM Easy to Use Ovulation Test is a rapid chromatographic immunoassay for the qualitative detection of Luteinizing Hormo
• 00850059915424 - GoldN LH Ovulation Rapid Test Midstream (Urine)(25-Pack) (OTC): 2024-03-04 A rapid immunochromatographic assay for the qualitative detection of Luteinizing Hormone (LH) surge for the detection of ovulati