AdexusDx hCG Control Set (unassayed) 401.009

GUDID 00858022006230

hCG Control Set (unassayed)

NOWDIAGNOSTICS, INC.

Total human chorionic gonadotropin (HCG) IVD, control Total human chorionic gonadotropin (HCG) IVD, control Total human chorionic gonadotropin (HCG) IVD, control Total human chorionic gonadotropin (HCG) IVD, control Total human chorionic gonadotropin (HCG) IVD, control Total human chorionic gonadotropin (HCG) IVD, control Total human chorionic gonadotropin (HCG) IVD, control Total human chorionic gonadotropin (HCG) IVD, control Total human chorionic gonadotropin (HCG) IVD, control Total human chorionic gonadotropin (HCG) IVD, control Total human chorionic gonadotropin (HCG) IVD, control Total human chorionic gonadotropin (HCG) IVD, control Total human chorionic gonadotropin (HCG) IVD, control Total human chorionic gonadotropin (HCG) IVD, control Total human chorionic gonadotropin (HCG) IVD, control Total human chorionic gonadotropin (HCG) IVD, control Total human chorionic gonadotropin (HCG) IVD, control Total human chorionic gonadotropin (HCG) IVD, control Total human chorionic gonadotropin IVD, control Total human chorionic gonadotropin IVD, control Total human chorionic gonadotropin IVD, control Total human chorionic gonadotropin IVD, control Total human chorionic gonadotropin IVD, control Total human chorionic gonadotropin IVD, control Total human chorionic gonadotropin IVD, control Total human chorionic gonadotropin IVD, control Total human chorionic gonadotropin IVD, control Total human chorionic gonadotropin IVD, control Total human chorionic gonadotropin IVD, control Total human chorionic gonadotropin IVD, control Total human chorionic gonadotropin IVD, control Total human chorionic gonadotropin IVD, control Total human chorionic gonadotropin 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.

• 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