Estrone RIA DSL8700

GUDID 15099590211615

Estrone RIA

IMMUNOTECH s.r.o.

Estrone (oestrone) IVD, kit, radioimmunoassay

• Primary Device ID: 15099590211615
• NIH Device Record Key: 5889863b-88e6-4455-9161-c048a5e469a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Estrone RIA
• Version Model Number: DSL8700
• Catalog Number: DSL8700
• 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	15099590211615 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K935013

FDA Product Code

• CGF: Radioimmunoassay, Estrone

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.

• 15099590211509 - DHEA-S-7 RIA: 2023-07-14 DHEA-S-7 RIA
• 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: 2023-07-14Estrone RIA
• 15099590211615 - Estrone RIA: 2023-07-14 Estrone RIA
• 15099590211622 - DHEA RIA: 2023-07-14 DHEA RIA