Multi Use 9 drug (CASE)

GUDID 00869419000298

Multi Use 9 drug (CASE)

Quest Diagnostics

Urine pH IVD, kit, rapid colorimetric, clinical
Primary Device ID00869419000298
NIH Device Record Key7b29947b-45b2-43ce-9c33-20fae6e2d320
Commercial Distribution StatusIn Commercial Distribution
Brand NameMulti Use 9 drug (CASE)
Version Model NumberDUE-197-232 (FUO)
Company DUNS189222334
Company NameQuest Diagnostics
Device Count25
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100869419000298 [Unit of Use]
GS110869419000264 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-01-01
Device Publish Date2023-12-22

Devices Manufactured by Quest Diagnostics

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00850054552075 - K-QUE-ACT-003 REV0022026-03-05 QCard Collection Kit (WHS)
00850054552082 - K-QUE-ACT-004 REV0022026-03-05 QCard Collection Kit
00850054552099 - K-QUE-ACT-005 REV0022026-03-05 QCard Collection Kit (WHS)
00850054552105 - K-QUE-ACT-006 REV0012026-03-05 QCard Collection Kit (WHS)
00850054552112 - K-QUE-ACT-007 REV0002026-03-05 QCard Collection Kit (WHS)
00850054552129 - K-QUE-KED-001 REV0002026-03-05 QCard Collection Kit
10850054552034 - US Blood And Urine Kit2024-05-09 US Blood And Urine Kit

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