IDG/Sanzay QC01

GUDID 00850053916236

For in vitro diagnostic use only. The Chemistry Control is to be used for monitoring the accuracy and precision of clinical chemistry procedures. This control contains constituents commonly of interest in a general chemistry control, including common drugs and thyroids.. The assayed multi-analyte control product is packaged with one level of analytes.

IDG/SANZAY Corporation

Multiple-type clinical chemistry analyte profile IVD, control

• Primary Device ID: 00850053916236
• NIH Device Record Key: 91d458ab-f46a-4c0d-8d0c-06097159af3d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IDG/Sanzay
• Version Model Number: 1
• Catalog Number: QC01
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850053916236 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K981339

FDA Product Code

• JJY: Multi-Analyte Controls, All Kinds (Assayed)

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: 2024-07-03
• Device Publish Date: 2024-06-25

On-Brand Devices [IDG/Sanzay]

• 00850053916007: Albumin reagent is used for the quantitative determination of albumin concentration in human ser
• 00850053916021: For the quantitative determination of alanine aminotransferase in serum used in routine examinat
• 00850053916014: For the quantitative determination of alkaline phosphatase in human serum.
• 00850053916038: For the quantitative determination of aspartate aminotransferase (AST) in human serum. The reage
• 00850053916229: The IDG Control Level 2 Low Abnormal is intended for use for quality assurance of in vitro diagn
• 00850053916212: The IDG Control Level 1 Normal is intended for use in quality assurance of in vitro diagnostic c
• 00850053916199: The IDG APTT-EA reagent is an in vitro diagnostic assay intended for use in determining activate
• 00850053916182: The IDG PT-HS reagent is an in vitro diagnostic assay intended for use in performing the one sta
• 00850053916175: The IDG HDL-Cholesterol reagent is intended for the in vitro quantitative determination of High
• 00850053916168: For the in vitro quantitative determination of Uric Acid in serum.
• 00850053916151: For the in vitro quantitative determination of Triglycerides in serum or plasma.
• 00850053916144: For the quantitative determination of total protein concentration in human serum.
• 00850053916137: Lactate Dehydrogenase LS (LDH-L) liquid reagent is intended to use for the In Vitro quantitative
• 00850053916120: Inorganic phosphorus (UV method) reagent is for the quantitative determination of inorganic phos
• 00850053916076: For the quantitative determination of calcium concentration in serum or plasma.
• 00850053916250: The HDL-LDL calibrator is used to establish the value of high density lipoprotein cholesterol an
• 00850053916243: For in vitro diagnostic use only. The Chemistry Control is to be used for monitoring the accura
• 00850053916236: For in vitro diagnostic use only. The Chemistry Control is to be used for monitoring the accura
• 00850053916113: For the In Vitro quantitative determination of glucose in human serum or plasma.
• 00850053916267: The Multi-Analyte Chemistry calibrator is for use as a calibrator of IDG Clinical chemistry assa
• 00850053916205: Calcium Chloride 0.020 M is a reagent for use only in the in vitro determination of Prothrombin