INS-IRMA

GUDID 05400569000438

INS-IRMA

Diasource Immunoassays S.A. SA

Insulin IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 05400569000438
• NIH Device Record Key: e0cd9ed3-8867-4ad0-a328-54c2931c7975
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INS-IRMA
• Version Model Number: KIP1251/KIP1254
• Company DUNS: 458777323
• Company Name: Diasource Immunoassays S.A. SA
• Device Count: 1
• DM Exempt: true
• 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: false
• 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	05400569000438 [Primary]

FDA Product Code

• CFP: RADIOIMMUNOASSAY, IMMUNOREACTIVE INSULIN

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: 2020-01-23
• Device Publish Date: 2020-01-15

Devices Manufactured by Diasource Immunoassays S.A. SA

• 05400569000674 - Estrone-RIA-CT: 2020-09-24 Estrone-RIA-CT
• 05400569000360 - E2 RIA CT: 2020-09-23 E2 RIA CT
• 05400569000650 - 11-DESOXYCORTISOL-RIA-CT: 2020-09-23 11-DESOXYCORTISOL-RIA-CT
• 05400569000049 - C-PEP-EASIA: 2020-09-22 C-PEP-EASIA
• 05400569000377 - FSH IRMA: 2020-09-22 FSH IRMA
• 05400569000865 - Androstenedione-ELISA: 2020-09-22 Androstenedione-ELISA
• 05400569000209 - IGF-1 ELISA: 2020-09-21 IGF-1 ELISA
• 05400569000414 - KIP1131: 2020-09-21 Urinary hGH IRMA