AdexusDx hCG Test 8001-25

GUDID 00858022006209

Box of 25 cartridges/tests

NOWDIAGNOSTICS, INC.

Human chorionic gonadotropin beta-core fragment (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 00858022006209
• NIH Device Record Key: 56277338-50dd-4b35-a5bb-52792aedac2a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AdexusDx hCG Test
• Version Model Number: 8001-25
• Catalog Number: 8001-25
• Company DUNS: 079541513
• Company Name: NOWDIAGNOSTICS, INC.
• Device Count: 25
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (479) 966-4511
• Email: duane.poorman@nowdx.com
• Phone: (479) 966-4511
• Email: duane.poorman@nowdx.com
• Phone: (479) 966-4511
• Email: duane.poorman@nowdx.com
• Phone: (479) 966-4511
• Email: duane.poorman@nowdx.com
• Phone: (479) 966-4511
• Email: duane.poorman@nowdx.com
• Phone: (479) 966-4511
• Email: duane.poorman@nowdx.com
• Phone: (479) 966-4511
• Email: duane.poorman@nowdx.com
• Phone: (479) 966-4511
• Email: duane.poorman@nowdx.com
• Phone: (479) 966-4511
• Email: duane.poorman@nowdx.com
• Phone: (479) 966-4511
• Email: duane.poorman@nowdx.com
• Phone: (479) 966-4511
• Email: duane.poorman@nowdx.com
• Phone: (479) 966-4511
• Email: duane.poorman@nowdx.com
• Phone: (479) 966-4511
• Email: duane.poorman@nowdx.com
• Phone: (479) 966-4511
• Email: duane.poorman@nowdx.com
• Phone: (479) 966-4511
• Email: duane.poorman@nowdx.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858022006186 [Unit of Use]
GS1	00858022006209 [Primary]
GS1	20858022006203 [Package]; Package: Case [40 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033297

FDA Product Code

• JHI: Visual, Pregnancy Hcg, Prescription Use

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-12-22

On-Brand Devices [AdexusDx hCG Test]

• 00858022006216: Box of 50 cartridges/tests
• 00858022006209: Box of 25 cartridges/tests
• 00858022006193: Box of one test cartridge