Medzah uACR Collection Kit

GUDID 20860013131221

Medzah uACR Collection Kit

Medzah Industries

Urine specimen collection kit IVD
Primary Device ID20860013131221
NIH Device Record Key425bbe01-92a2-40ae-8713-d009d42c1d81
Commercial Distribution StatusIn Commercial Distribution
Brand NameMedzah uACR Collection Kit
Version Model NumberMDZHUACR01
Company DUNS114193536
Company NameMedzah Industries
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 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
GS120860013131221 [Primary]

FDA Product Code

OIBBlood And Urine Collection Kit (Excludes Hiv Testing)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-12-03
Device Publish Date2024-11-25

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