AccessGUDID - DEVICE: Wampole ColorCard® Streptozyme® (10859035006221)

GUDID

Device Identifier (DI) Information

Brand Name: Wampole ColorCard® Streptozyme®
Version or Model: 46050
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ALERE NORTH AMERICA, LLC

Primary DI Number: 10859035006221
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 826027364 *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):	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:	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?
51719	Beta-haemolytic Group A Streptococcus total antibody IVD, kit, agglutination	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total antibodies to extracellular antigens from Group A beta-haemolytic Streptococcus bacteria in a clinical specimen, using an agglutination method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GTY	Antigens, All Groups, Streptococcus Spp.

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
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: f8aff050-c047-49dc-a796-02ca1f24114b
Public Version Date: October 25, 2018
Public Version Number: 1
DI Record Publish Date: September 24, 2018