Exploro Highly Sensitive 5-Panel Urine Drug Test MDP-1054

GUDID 06974246461205

Safecare Biotech (Hangzhou) Co., Ltd.

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Primary Device ID06974246461205
NIH Device Record Key4ad8f3d9-7e3b-475e-8a06-f00090f367ab
Commercial Distribution StatusIn Commercial Distribution
Brand NameExploro Highly Sensitive 5-Panel Urine Drug Test
Version Model Number2 tests
Catalog NumberMDP-1054
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
GS106974246461205 [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 Date2024-04-01
Device Publish Date2024-03-22

On-Brand Devices [Exploro Highly Sensitive 5-Panel Urine Drug Test]

0697424646124310 tests
069742464612367 tests
069742464612295 tests
069742464612123 tests
069742464612052 tests

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