ISE Serum Standard Set NA

GUDID 04987762129889

JEOL LTD.

Multiple clinical chemistry enzyme IVD, control

• Primary Device ID: 04987762129889
• NIH Device Record Key: 81943166-6304-4eea-a404-1b3217326548
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ISE Serum Standard Set NA
• Version Model Number: 781611351
• Company DUNS: 690565023
• Company Name: JEOL LTD.
• 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: false
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04987762129889 [Primary]

FDA Product Code

• JIX: Calibrator, Multi-Analyte Mixture
• 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: 2020-09-23
• Device Publish Date: 2020-09-15

Devices Manufactured by JEOL LTD.

• 04987762129759 - ISE Buffer (IS): 2020-10-19
• 04987762129766 - Reagent Probe S: 2020-09-23
• 04987762129773 - Reagent Probe Wash K: 2020-09-23
• 04987762129780 - Reagent Probe Wash 2: 2020-09-23
• 04987762129797 - Reagent Probe Wash 1: 2020-09-23
• 04987762129803 - Lamp Coolant C: 2020-09-23
• 04987762129810 - Cuvette Conditioner EX: 2020-09-23
• 04987762129827 - Cuvette Wash Solution 7: 2020-09-23