IDS-iSYS Insulin-like Growth Factor Binding Protei

GUDID 05060169690301

IMMUNODIAGNOSTIC SYSTEMS LIMITED

Insulin-like growth factor binding protein 3 (IGFBP-3) IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 05060169690301
• NIH Device Record Key: 4ecf0f79-b4d9-4cb3-96ad-b34895c01280
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IDS-iSYS Insulin-like Growth Factor Binding Protei
• Version Model Number: IS-4400
• Company DUNS: 494268600
• Company Name: IMMUNODIAGNOSTIC SYSTEMS LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +4401915190660
• Email: info.uk@idsplc.com
• Phone: +4401915190660
• Email: info.uk@idsplc.com
• Phone: +4401915190660
• Email: info.uk@idsplc.com
• Phone: +4401915190660
• Email: info.uk@idsplc.com
• Phone: +4401915190660
• Email: info.uk@idsplc.com
• Phone: +4401915190660
• Email: info.uk@idsplc.com
• Phone: +4401915190660
• Email: info.uk@idsplc.com
• Phone: +4401915190660
• Email: info.uk@idsplc.com
• Phone: +4401915190660
• Email: info.uk@idsplc.com
• Phone: +4401915190660
• Email: info.uk@idsplc.com
• Phone: +4401915190660
• Email: info.uk@idsplc.com
• Phone: +4401915190660
• Email: info.uk@idsplc.com
• Phone: +4401915190660
• Email: info.uk@idsplc.com
• Phone: +4401915190660
• Email: info.uk@idsplc.com
• Phone: +4401915190660
• Email: info.uk@idsplc.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Prior to first use. Store the cartridge and calibrators in the upright position in the dark. Do not freeze the cartridge.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Prior to first use. Store the cartridge and calibrators in the upright position in the dark. Do not freeze the cartridge.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Prior to first use. Store the cartridge and calibrators in the upright position in the dark. Do not freeze the cartridge.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Prior to first use. Store the cartridge and calibrators in the upright position in the dark. Do not freeze the cartridge.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Prior to first use. Store the cartridge and calibrators in the upright position in the dark. Do not freeze the cartridge.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Prior to first use. Store the cartridge and calibrators in the upright position in the dark. Do not freeze the cartridge.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Prior to first use. Store the cartridge and calibrators in the upright position in the dark. Do not freeze the cartridge.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Prior to first use. Store the cartridge and calibrators in the upright position in the dark. Do not freeze the cartridge.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Prior to first use. Store the cartridge and calibrators in the upright position in the dark. Do not freeze the cartridge.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Prior to first use. Store the cartridge and calibrators in the upright position in the dark. Do not freeze the cartridge.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Prior to first use. Store the cartridge and calibrators in the upright position in the dark. Do not freeze the cartridge.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Prior to first use. Store the cartridge and calibrators in the upright position in the dark. Do not freeze the cartridge.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Prior to first use. Store the cartridge and calibrators in the upright position in the dark. Do not freeze the cartridge.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Prior to first use. Store the cartridge and calibrators in the upright position in the dark. Do not freeze the cartridge.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Prior to first use. Store the cartridge and calibrators in the upright position in the dark. Do not freeze the cartridge.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060169690301 [Primary]

FDA Product Code

• CFL: Radioimmunoassay, Human Growth Hormone

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-04-01

On-Brand Devices [IDS-iSYS Insulin-like Growth Factor Binding Protei]

• 05060169690318: IS-4430
• 05060169690301: IS-4400