IDS-iSYS 25-Hydroxy Vitamin DS

GUDID 05060169690400

IMMUNODIAGNOSTIC SYSTEMS LIMITED

Multiple form 25-hydroxy Vitamin D IVD, reagent
Primary Device ID05060169690400
NIH Device Record Keyca81deca-49f1-43c3-8fbe-5b360c8a5e4d
Commercial Distribution StatusIn Commercial Distribution
Brand NameIDS-iSYS 25-Hydroxy Vitamin DS
Version Model NumberIS-2700S
Company DUNS494268600
Company NameIMMUNODIAGNOSTIC SYSTEMS LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
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

Customer Support Contacts

Phone+4401915190660
Emailinfo.uk@idsplc.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the cartridge and calibrators in an upright position in the dark. Do not freeze the cartridge or calibrators

Device Identifiers

Device Issuing AgencyDevice ID
GS105060169690400 [Primary]

FDA Product Code

MRGSystem, Test, Vitamin D

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-04-01

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05060169696532 - IDS ACTH II Control Set2023-08-31
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