Hemoglobin Total Normal Control HC-110

GUDID 00817869020168

ANALYTICAL CONTROL SYSTEMS INC

Inherited haemoglobinopathy IVD, control
Primary Device ID00817869020168
NIH Device Record Key3ff644e0-1ecd-44e8-aba8-d200c8fc261b
Commercial Distribution StatusIn Commercial Distribution
Brand NameHemoglobin Total Normal Control
Version Model NumberHC-110
Catalog NumberHC-110
Company DUNS038232682
Company NameANALYTICAL CONTROL SYSTEMS INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100817869020168 [Primary]
GS110817869020165 [Package]
Package: 6 pack [6 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KHGWhole Blood Hemoglobin Determination

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-04
Device Publish Date2019-01-31

Devices Manufactured by ANALYTICAL CONTROL SYSTEMS INC

00817869020359 - Hemoglobin Variant Control Kit2019-11-27
00817869020335 - Hemotec Whole Blood Control Kit Large2019-11-22 Whole Blood Control Kit containing 8 vials of each: SC-125, SC-126, and DW-101
00817869020342 - Hemotec Whole Blood Control Kit Small2019-11-22 Whole Blood Control Kit containing 2 vials of each: SC-125, SC-126, and DW-10
00817869020311 - Hemotec Whole Blood Control Kit Large2019-08-01
00817869020007 - .02M Calcium Chloride2019-03-04
00817869020014 - Slide Platelet Aggregation Test Reagent2019-03-04
00817869020052 - Hemoglobin AFSC Control2019-03-04
00817869020069 - Hemoglobin NAFSC Control2019-03-04

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