GoldN Easy to Use Ovulation Test GN013ST

GUDID 00850059915646

The GoldNTM Easy to Use Ovulation Test is a rapid chromatographic immunoassay for the qualitative detection of Luteinizing Hormone (LH) surge in urine to predict the time of ovulation. The test is intended for women who want to conceive. For in vitro diagnostic use. For over-the-counter use.

NOVODX Corporation

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

• Primary Device ID: 00850059915646
• NIH Device Record Key: 91a39451-ea83-43c9-9aa2-48cd289f7ea8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GoldN Easy to Use Ovulation Test
• Version Model Number: GN013ST10-US
• Catalog Number: GN013ST
• Company DUNS: 119046376
• Company Name: NOVODX 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: 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

• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850059915646 [Primary]

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-10-04
• Device Publish Date: 2024-02-22

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• 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: 2024-10-04The GoldNTM Easy to Use Ovulation Test is a rapid chromatographic immunoassay for the qualitative detection of Luteinizing Hormone (LH) surge in urine to predict the time of ovulation. The test is intended for women who want to conceive. For in vitro diagnostic use. For over-the-counter use.
• 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