Alfa Wassermann S2-87

GUDID 00857969006600

Hemoglobin A1c Calibrators

ALFA WASSERMANN, INC.

Glycated haemoglobin (HbA1c) IVD, calibrator

• Primary Device ID: 00857969006600
• NIH Device Record Key: 26baead4-90d4-45dc-89af-9c7d03c3d662
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alfa Wassermann
• Version Model Number: S2-87
• Catalog Number: S2-87
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857969006600 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063306

FDA Product Code

• JIS: Calibrator, Primary

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: 2020-04-13
• Device Publish Date: 2020-04-03

On-Brand Devices [Alfa Wassermann]

• 00857969006433: Lipid Controls
• 00857969006426: Hemoglobin A1c Controls
• 00857969006402: Level 2 Chemistry Control
• 00857969006396: Level 1 Chemistry Control
• 00857969006389: CAL A
• 00857969006372: STARLYTE V Fluid Pack
• 00857969006327: REFERENCE ELECTRODE SOLUTION
• 00857969006310: CAL B
• 00857969006204: Hemoglobin A1c Calibrators
• 00857969006198: Urine Standard
• 00857969006181: GemCal Reference Serum
• 00857969006051: Electrode, Chloride
• 00857969006044: Electrode, Potassium
• 00857969006037: Electrode, Sodium
• 00857969006600: Hemoglobin A1c Calibrators