Exploro Highly Sensitive Urine Drug Test (12-Panel) MDP-1124

GUDID 06974246462530

Safecare Biotech (Hangzhou) Co., Ltd.

Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Primary Device ID06974246462530
NIH Device Record Key9bc292eb-74bc-47e6-939f-eaf3819c4ebd
Commercial Distribution StatusIn Commercial Distribution
Brand NameExploro Highly Sensitive Urine Drug Test (12-Panel)
Version Model Number1 test
Catalog NumberMDP-1124
Company DUNS544349634
Company NameSafecare Biotech (Hangzhou) 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 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
GS106974246462530 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NFTTest, Amphetamine, 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 Date2025-08-07
Device Publish Date2025-07-30

On-Brand Devices [Exploro Highly Sensitive Urine Drug Test (12-Panel)]

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069742464625094 tests
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