Alfa Wassermann C2-87

GUDID 00857969006433

Lipid Controls

ALFA WASSERMANN, INC.

Multiple lipid analyte IVD, control
Primary Device ID00857969006433
NIH Device Record Key6c9760ed-b295-4fb3-bce6-b49940a84ae8
Commercial Distribution StatusIn Commercial Distribution
Brand NameAlfa Wassermann
Version Model NumberC2-87
Catalog NumberC2-87
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
Phone973-852-0158
EmailHKatz@alfawassermannUS.com
Phone973-852-0158
EmailHKatz@alfawassermannUS.com
Phone973-852-0158
EmailHKatz@alfawassermannUS.com
Phone973-852-0158
EmailHKatz@alfawassermannUS.com
Phone973-852-0158
EmailHKatz@alfawassermannUS.com
Phone973-852-0158
EmailHKatz@alfawassermannUS.com
Phone973-852-0158
EmailHKatz@alfawassermannUS.com
Phone973-852-0158
EmailHKatz@alfawassermannUS.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100857969006433 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JJYMulti-Analyte Controls, All Kinds (Assayed)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-10-10

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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