GoldN Easy to Use Pregnancy Test GN040ST

GUDID 00850059915639

The GoldNTM Easy to Use Pregnancy Test is a rapid, visual immunoassay for the qualitative detection of human chorionic gonadotropin(hCG) in urine. The test is an in vitro diagnostic device intended for use as an aid in the early detection of pregnancy. The GoldNTM Easy to Use Pregnancy Test is designed for self-testing use.

NOVODX Corporation

Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical

• Primary Device ID: 00850059915639
• NIH Device Record Key: e1182934-fe0d-49e7-88b5-2df15a5ef9c7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GoldN Easy to Use Pregnancy Test
• Version Model Number: GN040ST02-US
• Catalog Number: GN040ST
• 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 Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850059915639 [Primary]

FDA Product Code

• LCX: Kit, Test, Pregnancy, Hcg, 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: 2025-01-15
• Device Publish Date: 2025-01-07

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• 00850059915639 - GoldN Easy to Use Pregnancy Test: 2025-01-15The GoldNTM Easy to Use Pregnancy Test is a rapid, visual immunoassay for the qualitative detection of human chorionic gonadotropin(hCG) in urine. The test is an in vitro diagnostic device intended for use as an aid in the early detection of pregnancy. The GoldNTM Easy to Use Pregnancy Test is designed for self-testing use.
• 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
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