IDS-iSYS 17-OH Progesterone

GUDID 05060169690738

IMMUNODIAGNOSTIC SYSTEMS LIMITED

Progesterone IVD, kit, chemiluminescent immunoassay
Primary Device ID05060169690738
NIH Device Record Keycb001841-fe30-40ac-81bd-8c5f51db185b
Commercial Distribution StatusIn Commercial Distribution
Brand NameIDS-iSYS 17-OH Progesterone
Version Model NumberIS-5100
Company DUNS494268600
Company NameIMMUNODIAGNOSTIC SYSTEMS LIMITED
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 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
Special Storage Condition, SpecifyBetween 0 and 0 *Store the cartridge and calibrators in an upright position in the dark at 2 - 8 °C. Do not freeze the cartridge or the calibrators.

Device Identifiers

Device Issuing AgencyDevice ID
GS105060169690738 [Primary]

FDA Product Code

JLSRadioimmunoassay, Progesterone

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 Date2016-06-24

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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