AccessGUDID - DEVICE: HemosIL D-Dimer HS 500 (08426950485605)

GUDID

Device Identifier (DI) Information

Brand Name: HemosIL D-Dimer HS 500
Version or Model: 00020500100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 00020500100
Company Name: INSTRUMENTATION LABORATORY COMPANY

Primary DI Number: 08426950485605
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 557223252 *Terms of Use

Device Description: HemosIL D-Dimer HS 500

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?
47346	D-dimer IVD, kit, agglutination	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of D-dimer protein in a clinical specimen, using an agglutination method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DAP	FIBRINOGEN AND FIBRIN SPLIT PRODUCTS, ANTIGEN, ANTISERUM, CONTROL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K090264	000
K172903	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 and calibrator 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: 1c777e49-55cb-40bb-8526-576ff6fab533
Public Version Date: December 25, 2023
Public Version Number: 7
DI Record Publish Date: September 23, 2016