ZIOXX

GUDID 06937579914343

NANTONG EGENS BIOLOGY TECHNIC CO., LTD.

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

• Primary Device ID: 06937579914343
• NIH Device Record Key: e3110294-95fa-4bc0-9078-c39f9713cc0e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZIOXX
• Version Model Number: LH -S50
• Company DUNS: 654510689
• Company Name: NANTONG EGENS BIOLOGY TECHNIC CO., LTD.
• Device Count: 50
• 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	06937579914282 [Primary]
GS1	06937579914343 [Unit of Use]

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-22
• Device Publish Date: 2023-05-12

Devices Manufactured by NANTONG EGENS BIOLOGY TECHNIC CO., LTD.

• 06937579912370 - PARAID: 2023-08-21
• 06937579914596 - EGENS: 2023-08-21
• 06937579914602 - EGENS: 2023-08-21
• 06937579914619 - EGENS: 2023-08-21
• 06937579914343 - ZIOXX: 2023-05-22
• 06937579914343 - ZIOXX: 2023-05-22
• 06937579914091 - RITE AID: 2023-02-13
• 06937579914114 - RITE AID: 2023-02-13
• 06937579914138 - RITE AID: 2023-02-13