AccessGUDID - DEVICE: ASI RF Direct Slide Tests for Export (00816057020478)

GUDID

Device Identifier (DI) Information

Brand Name: ASI RF Direct Slide Tests for Export
Version or Model: NC-700025DC-E
Commercial Distribution Status: In Commercial Distribution
Catalog Number: NC-700025DC-E
Company Name: ARLINGTON SCIENTIFIC, INC.

Primary DI Number: 00816057020478
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 785966607 *Terms of Use

Device Description: Detection of Rheumatoid Factor

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):	No
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?
55112	Rheumatoid factor IVD, kit, agglutination	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of rheumatoid factor immunoglobulins in a clinical specimen, using an agglutination method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DHR	System, Test, Rheumatoid Factor

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K821319	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

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 25 Tests

Device Record Status

Public Device Record Key: d25c8d9e-f495-4a22-8886-7d6f721eb00e
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: July 08, 2016