ALDOLASE (ALS)

GUDID 05055273200072

RANDOX LABORATORIES LIMITED

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• Primary Device ID: 05055273200072
• NIH Device Record Key: 331330c4-bafe-48ca-8123-99117f4d311a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ALDOLASE (ALS)
• Version Model Number: AD189
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055273200072 [Primary]

FDA Product Code

• CJC: Fructose-1, 6-Diphosphate And Nadh (U.V.), Aldolase

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: 2023-07-06
• Device Publish Date: 2019-05-31

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