AccessGUDID - DEVICE: HemosIL Homocysteine (08426950453024)

GUDID

Device Identifier (DI) Information

Brand Name: HemosIL Homocysteine
Version or Model: 00020007800
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 00020007800
Company Name: INSTRUMENTATION LABORATORY COMPANY

Primary DI Number: 08426950453024
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 557223252 *Terms of Use

Device Description: HemosIL Homocysteine

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:	No
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?
53747	Homocysteine IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of homocysteine in a clinical specimen, using a spectrophotometry method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LPS	URINARY HOMOCYSTINE (NONQUANTITATIVE) TEST SYSTEM

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K061598	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
Storage Environment Temperature: between 2 and 8 Degrees Celsius
Special Storage Condition, Specify: Unopened reagents are stable until the expiration date shown on the vial when stored at 2-8°C.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5153766d-430a-4df6-86c7-fc1818e61d05
Public Version Date: July 06, 2023
Public Version Number: 6
DI Record Publish Date: September 23, 2016