IDS-iSYS Ostase® BAP

GUDID 05060169695801

IMMUNODIAGNOSTIC SYSTEMS LIMITED

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