IDS-iSYS Aldosterone

GUDID 05060169690363

IMMUNODIAGNOSTIC SYSTEMS LIMITED

Aldosterone IVD, reagent
Primary Device ID05060169690363
NIH Device Record Keya57af912-664b-4199-8bc6-7b390f03621a
Commercial Distribution StatusIn Commercial Distribution
Brand NameIDS-iSYS Aldosterone
Version Model NumberIS-3300
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS105060169690363 [Primary]

FDA Product Code

CJMRadioimmunoassay, Aldosterone

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

Devices Manufactured by IMMUNODIAGNOSTIC SYSTEMS LIMITED

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05060169696051 - IDS Beta CrossLaps® (CTX-I) Control Set2024-01-11
05060169696457 - IDS ACTH II2023-08-31
05060169696495 - IDS ACTH II Calibrator Set2023-08-31
05060169696532 - IDS ACTH II Control Set2023-08-31
05060169691148 - IDS-iSYS SDSpeed Calc2023-07-05
05060169691261 - IDS Androstenedione2023-07-05

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