AdexusDx hCG Control Set (unassayed) 401.009

GUDID 00858022006230

hCG Control Set (unassayed)

NOWDIAGNOSTICS, INC.

Total human chorionic gonadotropin (HCG) IVD, control

• Primary Device ID: 00858022006230
• NIH Device Record Key: a6267b2c-a5c9-4b29-8c5e-78b8d641a88f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AdexusDx hCG Control Set (unassayed)
• Version Model Number: 401.009
• Catalog Number: 401.009
• Company DUNS: 079541513
• Company Name: NOWDIAGNOSTICS, 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858022006230 [Primary]

FDA Product Code

• JJX: Single (Specified) Analyte Controls (Assayed And Unassayed)

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: 2023-02-22
• Device Publish Date: 2023-02-14

Devices Manufactured by NOWDIAGNOSTICS, INC.

• 00858022006001 - First To Know Syphilis Test: 2024-11-19 Inner package containing one-count device
• 00858022006230 - AdexusDx hCG Control Set (unassayed): 2023-02-22hCG Control Set (unassayed)
• 00858022006230 - AdexusDx hCG Control Set (unassayed): 2023-02-22 hCG Control Set (unassayed)
• 00858022006193 - AdexusDx hCG Test: 2018-07-06 Box of one test cartridge
• 00858022006209 - AdexusDx hCG Test: 2018-07-06 Box of 25 cartridges/tests
• 00858022006216 - AdexusDx hCG Test: 2018-07-06 Box of 50 cartridges/tests