AccessGUDID - DEVICE: IDS-iSYS 17-OH Progesterone Control Set (05060169690882)

GUDID

Device Identifier (DI) Information

Brand Name: IDS-iSYS 17-OH Progesterone Control Set
Version or Model: IS-5130
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: IMMUNODIAGNOSTIC SYSTEMS LIMITED

Primary DI Number: 05060169690882
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 494268600 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
54326	Progesterone IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of progesterone in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K161082	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Leave the controls at room temperature for 10 minutes and gently mix the bottles by hand before use. Care should be taken to avoid the formation of foam.
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 01eb4faa-c4b6-4c04-9d79-59475d1c1e88
Public Version Date: December 19, 2022
Public Version Number: 3
DI Record Publish Date: June 24, 2016