A1c-Cellular 211130

GUDID 00844509000945

A liquid control appropriate for immunoassay and ionic exchange HPLC methodologies. Contains one vial each of Level 1 and 2.

STRECK, INC.

Glycated haemoglobin (HbA1c) IVD, control
Primary Device ID00844509000945
NIH Device Record Keye715292e-7337-4e7e-bdda-9672fcf8c878
Commercial Distribution StatusIn Commercial Distribution
Brand NameA1c-Cellular
Version Model Number211130
Catalog Number211130
Company DUNS072915986
Company NameSTRECK, INC.
Device Count1
DM Exempttrue
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

Phone1-800-228-6090
Emailcustserv@streck.com

Device Dimensions

Total Volume2 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100844509000945 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

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 Date2016-09-19

On-Brand Devices [A1c-Cellular]

00844509000945A liquid control appropriate for immunoassay and ionic exchange HPLC methodologies. Contains on
00844509000938A liquid control appropriate for immunoassay and ionic exchange HPLC methodologies. Contains 3

Trademark Results [A1c-Cellular]

Mark Image

Registration | Serial
Company
Trademark
Application Date
A1C-CELLULAR
A1C-CELLULAR
78544055 3134491 Live/Registered
STRECK, INC.
2005-01-07

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