Hemoglobin Variant Control Kit HC-121

GUDID 00817869020359

ANALYTICAL CONTROL SYSTEMS INC

Inherited haemoglobinopathy IVD, control
Primary Device ID00817869020359
NIH Device Record Key0fc388ad-9c0b-4b3b-9144-99f9cb37c3c1
Commercial Distribution StatusIn Commercial Distribution
Brand NameHemoglobin Variant Control Kit
Version Model NumberHC-121
Catalog NumberHC-121
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 Kittrue
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
GS100817869020359 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-27
Device Publish Date2019-11-19

Devices Manufactured by ANALYTICAL CONTROL SYSTEMS INC

00817869020359 - Hemoglobin Variant Control Kit2019-11-27
00817869020359 - Hemoglobin Variant Control Kit2019-11-27
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
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

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.