WIZARD² Gamma Counter 2480-0010

GUDID 00812589020481

An automated gamma counter to detect and count gamma radiation emitted by clinical samples that were prepared through the addition of a radioactive reagent.

PERKINELMER SINGAPORE PTE. LTD.

Radioimmunoassay analyser IVD, semi-automated

• Primary Device ID: 00812589020481
• NIH Device Record Key: d4c4de9d-5099-442e-be88-5534f039fd3f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WIZARD² Gamma Counter
• Version Model Number: 2480-0010
• Catalog Number: 2480-0010
• Company DUNS: 894632777
• Company Name: PERKINELMER SINGAPORE PTE. 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812589020481 [Primary]

FDA Product Code

• JJJ: Counter (Beta, Gamma) 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: 2020-05-22
• Device Publish Date: 2020-05-14

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• 00812589020528: An automated gamma counter to detect and count gamma radiation emitted by clinical samples that
• 00812589020504: An automated gamma counter to detect and count gamma radiation emitted by clinical samples that
• 00812589020498: An automated gamma counter to detect and count gamma radiation emitted by clinical samples that
• 00812589020481: An automated gamma counter to detect and count gamma radiation emitted by clinical samples that
• 00812589020474: An automated gamma counter to detect and count gamma radiation emitted by clinical samples that
• 00812589020467: An automated gamma counter to detect and count gamma radiation emitted by clinical samples that
• 00812589020450: An automated gamma counter to detect and count gamma radiation emitted by clinical samples that
• 00812589020443: An automated gamma counter to detect and count gamma radiation emitted by clinical samples that
• 00812589020436: An automated gamma counter to detect and count gamma radiation emitted by clinical samples that
• 00812589020429: An automated gamma counter to detect and count gamma radiation emitted by clinical samples that