ISE Reference Solution Kit

GUDID 00811403011742

Diamond Diagnostics Inc.

Ion selective electrode (ISE) reference solution IVD, reagent
Primary Device ID00811403011742
NIH Device Record Key7a55c237-2e46-4075-9720-1e091bd52cbf
Commercial Distribution StatusIn Commercial Distribution
Brand NameISE Reference Solution Kit
Version Model NumberBT-6620941D
Company DUNS947514303
Company NameDiamond Diagnostics Inc.
Device Count2
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
GS100811403011742 [Unit of Use]
GS100811403011759 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-20
Device Publish Date2023-06-12

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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