IDS-iSYS 25 VitDS Calibration Verifiers

GUDID 05060169690929

IMMUNODIAGNOSTIC SYSTEMS LIMITED

Multiple form 25-hydroxy Vitamin D IVD, calibrator
Primary Device ID05060169690929
NIH Device Record Key0cdd4d14-6344-4244-b1b3-2a7a769a79e7
Commercial Distribution StatusIn Commercial Distribution
Brand NameIDS-iSYS 25 VitDS Calibration Verifiers
Version Model NumberIS-2535
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 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

Customer Support Contacts

Phone+4401915190660
Emailtechsupport.uk@idsplc.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store the calibration verifiers in an upright position.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105060169690929 [Primary]

FDA Product Code

JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

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 Date2016-12-22

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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