Whole Blood Control Level I SC-125

GUDID 00817869020250

ANALYTICAL CONTROL SYSTEMS INC

Activated clotting time (ACT) IVD, control
Primary Device ID00817869020250
NIH Device Record Key740bc911-4e5b-47ad-a414-d37857f0135b
Commercial Distribution StatusIn Commercial Distribution
Brand NameWhole Blood Control Level I
Version Model NumberSC-125
Catalog NumberSC-125
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
GS100817869020250 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JPASystem, Multipurpose For In Vitro Coagulation Studies

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

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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
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00817869020014 - Slide Platelet Aggregation Test Reagent2019-03-04
00817869020052 - Hemoglobin AFSC Control2019-03-04
00817869020069 - Hemoglobin NAFSC Control2019-03-04

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