HbA1c Reagent Set 501-421

GUDID 00812137012081

For the quantitative determination of Hemoglobin A1c (HbA1c) in human blood. The determination of HbA1c is most commonly performed for the evaluation of glycemic control in diabetes mellitus. HbA1c values provide an indication of glucose levels over the preceding 4-8 weeks. A higher HbA1c value indicates poorer glycemic control. For in vitro diagnostic use only.

CLINICAL DIAGNOSTIC SOLUTIONS, INC.

Glycated haemoglobin (HbA1c) IVD, reagent
Primary Device ID00812137012081
NIH Device Record Keycde1f175-c317-47c9-820d-d8d749feaa52
Commercial Distribution StatusIn Commercial Distribution
Brand NameHbA1c Reagent Set
Version Model NumberR1 x 30mL, R2 x 10mL, R3 x 125mL
Catalog Number501-421
Company DUNS048144997
Company NameCLINICAL DIAGNOSTIC SOLUTIONS, INC.
Device Count3
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

Phone8004533328
Emailquality@cdsolinc.com
Phone8004533328
Emailquality@cdsolinc.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

Device Identifiers

Device Issuing AgencyDevice ID
GS100812137012081 [Primary]
GS100812137012357 [Unit of Use]

FDA Product Code

LCPAssay, Glycosylated Hemoglobin

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 Date2016-10-12

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