Ultra-sensitive Estradiol RIA DSL4800

GUDID 15099590211523

Ultra-sensitive Estradiol RIA

IMMUNOTECH s.r.o.

Estradiol (oestradiol) (E2) IVD, kit, radioimmunoassay Estradiol (oestradiol) (E2) IVD, kit, radioimmunoassay Estradiol (oestradiol) (E2) IVD, kit, radioimmunoassay Estradiol (oestradiol) (E2) IVD, kit, radioimmunoassay Estradiol (oestradiol) (E2) IVD, kit, radioimmunoassay Estradiol (oestradiol) (E2) IVD, kit, radioimmunoassay Estradiol (oestradiol) (E2) IVD, kit, radioimmunoassay Estradiol (oestradiol) (E2) IVD, kit, radioimmunoassay Estradiol (oestradiol) (E2) IVD, kit, radioimmunoassay Estradiol (oestradiol) (E2) IVD, kit, radioimmunoassay Estradiol (oestradiol) (E2) IVD, kit, radioimmunoassay Estradiol (oestradiol) (E2) IVD, kit, radioimmunoassay Estradiol (oestradiol) (E2) IVD, kit, radioimmunoassay Estradiol (oestradiol) (E2) IVD, kit, radioimmunoassay Estradiol (oestradiol) (E2) IVD, kit, radioimmunoassay Estradiol (oestradiol) (E2) IVD, kit, radioimmunoassay Estradiol (oestradiol) (E2) IVD, kit, radioimmunoassay Estradiol (oestradiol) (E2) IVD, kit, radioimmunoassay

• Primary Device ID: 15099590211523
• NIH Device Record Key: 9a84fcf3-81ed-488b-8c40-74bf8e7fcfa9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ultra-sensitive Estradiol RIA
• Version Model Number: DSL4800
• Catalog Number: DSL4800
• Company DUNS: 360561849
• Company Name: IMMUNOTECH s.r.o.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	15099590211523 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K953605

FDA Product Code

• CHP: Radioimmunoassay, Estradiol

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: 2023-07-14
• Device Publish Date: 2023-07-06

Devices Manufactured by IMMUNOTECH s.r.o.

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• 15099590211523 - Ultra-sensitive Estradiol RIA: 2023-07-14 Ultra-sensitive Estradiol RIA
• 15099590211530 - ACTIVE Free Testosterone RIA: 2023-07-14 ACTIVE Free Testosterone RIA
• 15099590211547 - Estrone-sulfate RIA: 2023-07-14 Estrone-sulfate RIA
• 15099590211615 - Estrone RIA: 2023-07-14 Estrone RIA
• 15099590211622 - DHEA RIA: 2023-07-14 DHEA RIA