Red Test Dye

GUDID 00811403016013

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 ID00811403016013
NIH Device Record Key6a2ab8a7-c31a-4cd6-b1d3-f66f95e98014
Commercial Distribution StatusIn Commercial Distribution
Brand NameRed Test Dye
Version Model NumberME-2578D
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100811403016013 [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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