Sure-Aid

GUDID 06937579911601

NANTONG EGENS BIOLOGY TECHNIC CO., LTD.

Human chorionic gonadotropin alpha-subunit (alpha-HCG) IVD, calibrator Human chorionic gonadotropin alpha-subunit IVD, calibrator Human chorionic gonadotropin alpha-subunit IVD, calibrator Human chorionic gonadotropin alpha-subunit IVD, calibrator Human chorionic gonadotropin alpha-subunit IVD, calibrator Human chorionic gonadotropin alpha-subunit IVD, calibrator Human chorionic gonadotropin alpha-subunit IVD, calibrator Human chorionic gonadotropin alpha-subunit IVD, calibrator Human chorionic gonadotropin alpha-subunit IVD, calibrator Human chorionic gonadotropin alpha-subunit IVD, calibrator Human chorionic gonadotropin alpha-subunit IVD, calibrator Human chorionic gonadotropin alpha-subunit IVD, calibrator Human chorionic gonadotropin alpha-subunit IVD, calibrator Human chorionic gonadotropin alpha-subunit IVD, calibrator Human chorionic gonadotropin alpha-subunit IVD, calibrator Human chorionic gonadotropin alpha-subunit IVD, calibrator
Primary Device ID06937579911601
NIH Device Record Key5459cb00-0ab6-4483-ba6c-94ed809cebdd
Commercial Distribution StatusIn Commercial Distribution
Brand NameSure-Aid
Version Model NumberHCG-C01
Company DUNS654510689
Company NameNANTONG EGENS BIOLOGY TECHNIC CO., LTD.
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
GS106937579911601 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LCXKit, Test, Pregnancy, Hcg, Over The Counter

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 Date2017-02-10

On-Brand Devices [Sure-Aid]

06937579911618HCG-M01
06937579911601HCG-C01

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