ACE C2-85

GUDID 00857969006419

Urine Chemistry Controls

ALFA WASSERMANN, INC.

Multiple urine analyte IVD, control
Primary Device ID00857969006419
NIH Device Record Keydbbec72b-e360-46a1-83d6-d990942a1c58
Commercial Distribution StatusIn Commercial Distribution
Brand NameACE
Version Model NumberC2-85
Catalog NumberC2-85
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
GS100857969006419 [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 [ACE]

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

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