IDG/Sanzay C105

GUDID 00850053916076

For the quantitative determination of calcium concentration in serum or plasma.

IDG/SANZAY Corporation

Calcium (Ca2+) IVD, reagent Calcium (Ca2+) IVD, reagent Calcium (Ca2+) IVD, reagent Calcium (Ca2+) IVD, reagent Calcium (Ca2+) IVD, reagent Calcium (Ca2+) IVD, reagent Calcium (Ca2+) IVD, reagent Calcium (Ca2+) IVD, reagent Calcium (Ca2+) IVD, reagent Calcium (Ca2+) IVD, reagent Calcium (Ca2+) IVD, reagent Calcium (Ca2+) IVD, reagent Calcium (Ca2+) IVD, reagent Calcium (Ca2+) IVD, reagent Calcium (Ca2+) IVD, reagent Calcium (Ca2+) IVD, reagent Calcium (Ca2+) IVD, reagent Calcium (Ca2+) IVD, reagent

• Primary Device ID: 00850053916076
• NIH Device Record Key: 39558e89-60da-4e2b-a910-ad5254c9011e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IDG/Sanzay
• Version Model Number: 1
• Catalog Number: C105
• Company DUNS: 948875013
• Company Name: IDG/SANZAY Corporation
• 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: false
• Device Combination Product: false
• Single Use: false
• 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: true

Device Dimensions

• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850053916076 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K921625

FDA Product Code

• CIC: Cresolphthalein Complexone, Calcium

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: 2024-01-23
• Device Publish Date: 2024-01-15

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