AccessGUDID - DEVICE: Detector Rheumacol (10722355001507)

GUDID

Device Identifier (DI) Information

Brand Name: Detector Rheumacol
Version or Model: RH-50
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: IMMUNOSTICS COMPANY, INC

Primary DI Number: 10722355001507
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 119214195 *Terms of Use

Device Description: A rapid color enhanced hemagglutination slide test for the detection of rheumatoid factor in serum or synovial fluid

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):	Yes
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:	Yes
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 [?]
Premarket Submission Number Not Available/Not Released

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: Do not freeze

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a4eee6e4-967e-4358-9542-93575de444a3
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 21, 2016