IDS-iSYS Ostase® BAP

GUDID 05060169695801

IMMUNODIAGNOSTIC SYSTEMS LIMITED

Bone alkaline phosphatase (BALP) IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 05060169695801
• NIH Device Record Key: 0c935c8d-c7ee-4d47-abb9-ae656d1eb3ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IDS-iSYS Ostase® BAP
• Version Model Number: IS-2800US
• Company DUNS: 494268600
• Company Name: IMMUNODIAGNOSTIC SYSTEMS LIMITED
• 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: true
• 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

Customer Support Contacts

• Phone: +4401915190
• Email: techsupport.uk@idsplc.com
• Phone: +4401915190
• Email: techsupport.uk@idsplc.com
• Phone: +4401915190
• Email: techsupport.uk@idsplc.com
• Phone: +4401915190
• Email: techsupport.uk@idsplc.com
• Phone: +4401915190
• Email: techsupport.uk@idsplc.com
• Phone: +4401915190
• Email: techsupport.uk@idsplc.com
• Phone: +4401915190
• Email: techsupport.uk@idsplc.com
• Phone: +4401915190
• Email: techsupport.uk@idsplc.com
• Phone: +4401915190
• Email: techsupport.uk@idsplc.com
• Phone: +4401915190
• Email: techsupport.uk@idsplc.com
• Phone: +4401915190
• Email: techsupport.uk@idsplc.com
• Phone: +4401915190
• Email: techsupport.uk@idsplc.com
• Phone: +4401915190
• Email: techsupport.uk@idsplc.com
• Phone: +4401915190
• Email: techsupport.uk@idsplc.com
• Phone: +4401915190
• Email: techsupport.uk@idsplc.com
• Phone: +4401915190
• Email: techsupport.uk@idsplc.com
• Phone: +4401915190
• Email: techsupport.uk@idsplc.com
• Phone: +4401915190
• Email: techsupport.uk@idsplc.com
• Phone: +4401915190
• Email: techsupport.uk@idsplc.com
• Phone: +4401915190
• Email: techsupport.uk@idsplc.com
• Phone: +4401915190
• Email: techsupport.uk@idsplc.com
• Phone: +4401915190
• Email: techsupport.uk@idsplc.com
• Phone: +4401915190
• Email: techsupport.uk@idsplc.com
• Phone: +4401915190
• Email: techsupport.uk@idsplc.com
• Phone: +4401915190
• Email: techsupport.uk@idsplc.com
• Phone: +4401915190
• Email: techsupport.uk@idsplc.com
• Phone: +4401915190
• Email: techsupport.uk@idsplc.com
• Phone: +4401915190
• Email: techsupport.uk@idsplc.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the cartridge in an upright position in the dark at 2 - 8 °C. Do not freeze the cartridge
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the cartridge in an upright position in the dark at 2 - 8 °C. Do not freeze the cartridge
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the cartridge in an upright position in the dark at 2 - 8 °C. Do not freeze the cartridge
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the cartridge in an upright position in the dark at 2 - 8 °C. Do not freeze the cartridge
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the cartridge in an upright position in the dark at 2 - 8 °C. Do not freeze the cartridge
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the cartridge in an upright position in the dark at 2 - 8 °C. Do not freeze the cartridge
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the cartridge in an upright position in the dark at 2 - 8 °C. Do not freeze the cartridge
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the cartridge in an upright position in the dark at 2 - 8 °C. Do not freeze the cartridge
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the cartridge in an upright position in the dark at 2 - 8 °C. Do not freeze the cartridge
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the cartridge in an upright position in the dark at 2 - 8 °C. Do not freeze the cartridge
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the cartridge in an upright position in the dark at 2 - 8 °C. Do not freeze the cartridge
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the cartridge in an upright position in the dark at 2 - 8 °C. Do not freeze the cartridge
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the cartridge in an upright position in the dark at 2 - 8 °C. Do not freeze the cartridge
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the cartridge in an upright position in the dark at 2 - 8 °C. Do not freeze the cartridge
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the cartridge in an upright position in the dark at 2 - 8 °C. Do not freeze the cartridge
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the cartridge in an upright position in the dark at 2 - 8 °C. Do not freeze the cartridge
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the cartridge in an upright position in the dark at 2 - 8 °C. Do not freeze the cartridge
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the cartridge in an upright position in the dark at 2 - 8 °C. Do not freeze the cartridge
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the cartridge in an upright position in the dark at 2 - 8 °C. Do not freeze the cartridge
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the cartridge in an upright position in the dark at 2 - 8 °C. Do not freeze the cartridge
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the cartridge in an upright position in the dark at 2 - 8 °C. Do not freeze the cartridge
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the cartridge in an upright position in the dark at 2 - 8 °C. Do not freeze the cartridge
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the cartridge in an upright position in the dark at 2 - 8 °C. Do not freeze the cartridge
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the cartridge in an upright position in the dark at 2 - 8 °C. Do not freeze the cartridge
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the cartridge in an upright position in the dark at 2 - 8 °C. Do not freeze the cartridge
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the cartridge in an upright position in the dark at 2 - 8 °C. Do not freeze the cartridge
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the cartridge in an upright position in the dark at 2 - 8 °C. Do not freeze the cartridge
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the cartridge in an upright position in the dark at 2 - 8 °C. Do not freeze the cartridge

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060169695801 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200475

FDA Product Code

• CIN: Electrophoretic Separation, Alkaline Phosphatase Isoenzymes

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: 2021-03-16
• Device Publish Date: 2021-03-08

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• 05060169696051 - IDS Beta CrossLaps® (CTX-I) Control Set: 2024-01-11
• 05060169696457 - IDS ACTH II: 2023-08-31
• 05060169696495 - IDS ACTH II Calibrator Set: 2023-08-31
• 05060169696532 - IDS ACTH II Control Set: 2023-08-31
• 05060169691148 - IDS-iSYS SDSpeed Calc: 2023-07-05
• 05060169691261 - IDS Androstenedione: 2023-07-05