AccessGUDID - DEVICE: 1,25-Dihydroxy Vitamin D EIA (05060169690097)

GUDID

Device Identifier (DI) Information

Brand Name: 1,25-Dihydroxy Vitamin D EIA
Version or Model: AC-62F1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: IMMUNODIAGNOSTIC SYSTEMS LIMITED

Primary DI Number: 05060169690097
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?
54487	1,25-Dihydroxy vitamin D3 IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of 1,25-dihydroxy vitamin D3 in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MRG	System, Test, Vitamin D

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K051110	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: Store upon receipt at 2 to 8 degrees celsius
Storage Environment Temperature: between 2 and 8 Degrees Celsius
Handling Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 09a79f15-743b-4233-9da5-ac95c93a10bf
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: April 01, 2016