ALKALINE DETERGENT (Alkaline Detergent) RX8108

GUDID 05055273210385

Alkaline Detergent is used for cleaning the instrument probe and reaction cuvettes.

RANDOX LABORATORIES LIMITED

Wash/cleaning solution IVD, automated/semi-automated system Wash/cleaning solution IVD, automated/semi-automated system Wash/cleaning solution IVD, automated/semi-automated system Wash/cleaning solution IVD, automated/semi-automated system Wash/cleaning solution IVD, automated/semi-automated system Wash/cleaning solution IVD, automated/semi-automated system Wash/cleaning solution IVD, automated/semi-automated system Wash/cleaning solution IVD, automated/semi-automated system Wash/cleaning solution IVD, automated/semi-automated system Wash/cleaning solution IVD, automated/semi-automated system Wash/cleaning solution IVD, automated/semi-automated system Wash/cleaning solution IVD, automated/semi-automated system Wash/cleaning solution IVD, automated/semi-automated system Wash/cleaning solution IVD, automated/semi-automated system

• Primary Device ID: 05055273210385
• NIH Device Record Key: 6c7682b9-7812-4fb6-8b7a-55cb8088775b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ALKALINE DETERGENT (Alkaline Detergent)
• Version Model Number: RX8108
• Catalog Number: RX8108
• Company DUNS: 227530649
• Company Name: RANDOX LABORATORIES 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: +442894451070
• Email: technical.services@randox.com
• Phone: +442894451070
• Email: technical.services@randox.com
• Phone: +442894451070
• Email: technical.services@randox.com
• Phone: +442894451070
• Email: technical.services@randox.com
• Phone: +442894451070
• Email: technical.services@randox.com
• Phone: +442894451070
• Email: technical.services@randox.com
• Phone: +442894451070
• Email: technical.services@randox.com
• Phone: +442894451070
• Email: technical.services@randox.com
• Phone: +442894451070
• Email: technical.services@randox.com
• Phone: +442894451070
• Email: technical.services@randox.com
• Phone: +442894451070
• Email: technical.services@randox.com
• Phone: +442894451070
• Email: technical.services@randox.com
• Phone: +442894451070
• Email: technical.services@randox.com
• Phone: +442894451070
• Email: technical.services@randox.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055273210385 [Primary]

FDA Product Code

• JJE: Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

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: 2022-10-03
• Device Publish Date: 2022-09-23

Devices Manufactured by RANDOX LABORATORIES LIMITED

• 05055273219951 - ESSENTIAL PACKAGE SAMPLE COLLECTION KIT (USA): 2024-02-07 The Blood Sample Collection Kit is intended for use in the collection and transport of a blood sample, taken by a trained phlebo
• 05055273219968 - EXTENDED PACKAGE SAMPLE COLLECTION KIT (USA): 2024-02-07 The Blood Sample Collection Kit is intended for use in the collection and transport of a blood sample, taken by a trained phlebo
• 05055273219999 - EXTENDED PACKAGE SAMPLE COLLECTION KIT (USA U60): 2024-02-07 The Blood Sample Collection Kit is intended for use in the collection and transport of a blood sample, taken by a trained phlebo
• 05055273218480 - BNP CONTROLS FOR BECKMAN (BNP CONTROL): 2023-12-29 The BNP Controls for Beckman (CQ10520) are intended for use with in vitro diagnostic assays for the quantitative determination o
• 05055273218497 - BNP CONTROLS FOR ABBOTT (BNP CONTROL): 2023-12-29 The BNP Controls for Abbott (CQ10521) are intended for use with in vitro diagnostic assays for the quantitative determination of
• 05055273218725 - XANTHOCHROMIA POSITIVE CONTROL (XANTHOCHROMIA ): 2023-12-29 The Xanthochromia Positive Control is intended for use with in vitro diagnostic assays for the quantitative determination of Bil
• 05055273218732 - XANTHOCHROMIA NEGATIVE CONTROL (XANTHOCHROMIA ): 2023-12-29 The Xanthochromia Negative Control is intended for use with in vitro diagnostic assays for the quantitative determination of Bil
• 05055273218992 - PRE-ECLAMPSIA CONTROL LEVEL 3: 2023-12-29 The Pre eclampsia Control Level 3 is intended for use with in vitro diagnostic assays for the quantitative determination of plac