Troubleshooting Service Kit

GUDID 00811403015993

Diamond Diagnostics Inc.

Ion-selective analyser IVD Ion-selective analyser IVD Ion-selective analyser IVD Ion-selective analyser IVD Ion-selective analyser IVD Ion-selective analyser IVD Ion-selective analyser IVD Ion-selective analyser IVD Ion-selective analyser IVD Ion-selective analyser IVD Ion-selective analyser IVD Ion-selective analyser IVD Ion-selective analyser IVD Ion-selective analyser IVD Ion-selective analyser IVD Ion-selective analyser IVD
Primary Device ID00811403015993
NIH Device Record Keyece367f6-eeb2-46af-a668-7cc885f91b68
Commercial Distribution StatusIn Commercial Distribution
Brand NameTroubleshooting Service Kit
Version Model NumberME-2572D
Company DUNS947514303
Company NameDiamond Diagnostics Inc.
Device Count1
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 Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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
GS100811403015993 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-21
Device Publish Date2023-06-13

Devices Manufactured by Diamond Diagnostics Inc.

00811403010158 - Photometer Lamp2023-06-21
00811403010240 - Reference Solution2023-06-21
00811403013074 - Pump Tubing Kit2023-06-21
00811403013173 - C1/C2 Cleaning Solution2023-06-21
00811403010387 - Wash Pack2023-06-21
00811403013296 - pH Electrode2023-06-21
00811403013302 - Calcium Electrode2023-06-21
00811403013319 - Potassium Electrode2023-06-21
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