Alfa Wassermann S2-86

GUDID 00857969006204

Hemoglobin A1c Calibrators

ALFA WASSERMANN, INC.

Glycated haemoglobin (HbA1c) IVD, calibrator
Primary Device ID00857969006204
NIH Device Record Keya414c519-ef22-4458-b968-9a247b85e9a8
Commercial Distribution StatusIn Commercial Distribution
Brand NameAlfa Wassermann
Version Model NumberS2-86
Catalog NumberS2-86
Company DUNS781990924
Company NameALFA WASSERMANN, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone973-852-0158
EmailHKatz@AlfaWassermannUS.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100857969006204 [Primary]

FDA Product Code

JISCalibrator, Primary

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-24

On-Brand Devices [Alfa Wassermann]

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

Trademark Results [Alfa Wassermann]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ALFA WASSERMANN
ALFA WASSERMANN
76618507 3238600 Live/Registered
ALFASIGMA S.P.A.
2004-10-29

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