Luteinizing Hormone Rapid Test Strip LH-1011

GUDID 06974246460765

Safecare Biotech (Hangzhou) Co., Ltd.

Luteinizing hormone (LH) IVD, kit, rapid ICT, self-testing
Primary Device ID06974246460765
NIH Device Record Key56a268fe-9fe3-47b1-8027-de652c4fc3b6
Commercial Distribution StatusIn Commercial Distribution
Brand NameLuteinizing Hormone Rapid Test Strip
Version Model NumberLH-1011
Catalog NumberLH-1011
Company DUNS544349634
Company NameSafecare Biotech (Hangzhou) Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS106974246460765 [Primary]

FDA Product Code

NGETest, Luteinizing Hormone (Lh), Over The Counter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-02-24
Device Publish Date2023-02-16

Devices Manufactured by Safecare Biotech (Hangzhou) Co., Ltd.

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