ACE SA1052

GUDID 00857969006662

ALT Reagent

ALFA WASSERMANN, INC.

Alanine aminotransferase (ALT) IVD, reagent

• Primary Device ID: 00857969006662
• NIH Device Record Key: 32adfdb4-6e87-4ba6-9bec-5e2893f9f729
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACE
• Version Model Number: SA1052
• Catalog Number: SA1052
• Company DUNS: 781990924
• Company Name: ALFA WASSERMANN, INC.
• 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: 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: 973-852-0178
• Email: AGennis@AlfaWassermannUS.com
• Phone: 973-852-0178
• Email: AGennis@AlfaWassermannUS.com
• Phone: 973-852-0178
• Email: AGennis@AlfaWassermannUS.com
• Phone: 973-852-0178
• Email: AGennis@AlfaWassermannUS.com
• Phone: 973-852-0178
• Email: AGennis@AlfaWassermannUS.com
• Phone: 973-852-0178
• Email: AGennis@AlfaWassermannUS.com
• Phone: 973-852-0178
• Email: AGennis@AlfaWassermannUS.com
• Phone: 973-852-0178
• Email: AGennis@AlfaWassermannUS.com
• Phone: 973-852-0178
• Email: AGennis@AlfaWassermannUS.com
• Phone: 973-852-0178
• Email: AGennis@AlfaWassermannUS.com
• Phone: 973-852-0178
• Email: AGennis@AlfaWassermannUS.com
• Phone: 973-852-0178
• Email: AGennis@AlfaWassermannUS.com
• Phone: 973-852-0178
• Email: AGennis@AlfaWassermannUS.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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857969006662 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113382

FDA Product Code

• CKA: Nadh Oxidation/Nad Reduction, Alt/Sgpt

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: 2020-07-09
• Device Publish Date: 2020-07-01

On-Brand Devices [ACE]

• 00857969006594: HDL-C Reagent
• 00857969006587: Magnesium Reagent
• 00857969006570: Inorganic Phosphorus U.V. Reagent
• 00857969006563: γ-GT Reagent
• 00857969006556: ALT Reagent
• 00857969006549: Lipase Reagent
• 00857969006532: HDL-C Reagent
• 00857969006525: LDL-C Reagent
• 00857969006518: Uric Acid Reagent
• 00857969006501: Triglycerides Reagent
• 00857969006495: Total Iron Reagent
• 00857969006488: Cholesterol Reagent
• 00857969006471: LDL-C Reagent
• 00857969006464: Uric Acid Reagent
• 00857969006457: Triglycerides Reagent
• 00857969006440: Cholesterol Reagent
• 00857969006419: Urine Chemistry Controls
• 00857969006365: Starlyte III Fluid Pack
• 00857969006358: Urine Diluent
• 00857969006341: Starlyte Sodium Electrode Conditioner
• 00857969006334: Starlyte Cleaning Solution
• 00857969006303: Alkaline Phosphatase Reagent
• 00857969006297: Alkaline Phosphatase Reagent
• 00857969006280: LDH-L Reagent
• 00857969006273: T4 Reagent
• 00857969006266: BUN / UREA Reagent
• 00857969006259: AST Reagent
• 00857969006242: Hemoglobin A1c Reagent
• 00857969006235: Total Protein Reagent
• 00857969006228: Amylase Reagent
• 00857969006211: T4 Calibrators
• 00857969006174: AST Reagent
• 00857969006167: Ferritin Application Kit
• 00857969006150: Carbon Dioxide Reagent
• 00857969006143: CK Reagent
• 00857969006136: Albumin Reagent
• 00857969006129: Glucose Reagent
• 00857969006112: Creatinine Reagent
• 00857969006105: Calcium-Arsenazo Reagent
• 00857969006099: Total Bilirubin Reagent
• 00857969006082: Direct Bilirubin Reagent
• 00857969006075: CK Reagent
• 00857969006068: Creatinine Reagent
• 00857969006020: Direct Total Iron-Binding Capacity (TIBC) Reagent
• 00857969006013: LDL Cholesterol (LDL-C) Calibrator
• 00857969006006: KIT, DIRECT TIBC CALIBRATOR
• 00857969006617: Hemoglobin A1c Reagent
• 00857969006655: ISE CLEANING AND SODIUM ELECTRODE CONDITIONER
• 00857969006648: ISE WASH
• 00857969006631: SYSTEM DILUENT