AccessGUDID - DEVICE: STREPAIM (00695684730253)

GUDID

Device Identifier (DI) Information

Brand Name: STREPAIM
Version or Model: 73025
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: GERMAINE LABORATORIES, INC

Primary DI Number: 00695684730253
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 25
Labeler D-U-N-S® Number*: 176458115 *Terms of Use

Device Description: A rapid dipstick test for the qualitative detection of group A streptococcal antigen from throat swabs.

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:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
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?
30493	Beta-haemolytic Group A Streptococcus streptokinase antibody IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to streptokinase enzyme produced by Group A beta-haemolytic Streptococcus bacteria in a clinical specimen, using an enzyme immunoassay (EIA) 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: 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2bbe612d-75cc-4e4d-9569-ef96cf17a247
Public Version Date: March 11, 2019
Public Version Number: 1
DI Record Publish Date: February 06, 2019