AST (SGOT) Reagent Set 501-401

GUDID 00812137011886

For the quantitative determination of Aspartate Aminotransferase (AST) in human serum. AST is widely distributed in tissues with the highest concentrations found in the liver, heart, skeletal muscle and kidneys. Diseases involving any of these tissues can lead to elevated levels of AST in serum. Following myocardial infarction, AST levels are elevated and reach a peak after 48 to 60 hours. Hepatobiliary diseases such as cirrhosis, metastatic carcinoma and viral hepatitis can show increased levels of AST. Other disorders which can lead to an elevated level of AST are muscular dystrophy, dermatomyositis, acute pancreatitis and infectious mononucleosis.

CLINICAL DIAGNOSTIC SOLUTIONS, INC.

Total aspartate aminotransferase (AST) IVD, kit, enzyme spectrophotometry

• Primary Device ID: 00812137011886
• NIH Device Record Key: 783d736c-afd3-4615-b91e-17cd423abd8b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AST (SGOT) Reagent Set
• Version Model Number: R1 x 500mL, R2 x 125mL
• Catalog Number: 501-401
• Company DUNS: 048144997
• Company Name: CLINICAL DIAGNOSTIC SOLUTIONS, INC.
• Device Count: 2
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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: false

Customer Support Contacts

• Phone: 8004533328
• Email: quality@cdsolinc.com
• Phone: 8004533328
• Email: quality@cdsolinc.com
• Phone: 8004533328
• Email: quality@cdsolinc.com
• Phone: 8004533328
• Email: quality@cdsolinc.com
• Phone: 8004533328
• Email: quality@cdsolinc.com
• Phone: 8004533328
• Email: quality@cdsolinc.com
• Phone: 8004533328
• Email: quality@cdsolinc.com
• Phone: 8004533328
• Email: quality@cdsolinc.com
• Phone: 8004533328
• Email: quality@cdsolinc.com
• Phone: 8004533328
• Email: quality@cdsolinc.com
• Phone: 8004533328
• Email: quality@cdsolinc.com
• Phone: 8004533328
• Email: quality@cdsolinc.com
• Phone: 8004533328
• Email: quality@cdsolinc.com
• Phone: 8004533328
• Email: quality@cdsolinc.com
• Phone: 8004533328
• Email: quality@cdsolinc.com
• Phone: 8004533328
• Email: quality@cdsolinc.com
• Phone: 8004533328
• Email: quality@cdsolinc.com

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	00812137011886 [Primary]
GS1	00812137012241 [Unit of Use]

FDA Product Code

• CIT: Nadh Oxidation/Nad Reduction, Ast/Sgot

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: 2018-03-29
• Device Publish Date: 2016-10-12

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• 00081213701184 - Albumin Reagent: 2018-03-29 For the quantitative determination of Albumin in serum.
• 00812137010216 - Boule Con-Diff Tri-Level: 2018-03-29 For in vitro diagnostic use as a control to monitor the performance of multi- parameter hematology instruments. Boule Con-Diff T