AccessGUDID - DEVICE: Polyvalent Shigella Slide Antisera - flexneri 1-6 X & Y (05060472462725)

GUDID

Device Identifier (DI) Information

Brand Name: Polyvalent Shigella Slide Antisera - flexneri 1-6 X & Y
Version or Model: PL.6901
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PL.6901
Company Name: PRO-LAB, INCORPORATED

Primary DI Number: 05060472462725
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 960418395 *Terms of Use

Device Description: Shigella are differentiated from the closely related Escherichia coli on the basis of pathogenicity, physiology and serology. Pro-Lab polyvalent Shigella antisera are intended to aid in the serological identification after culture, isolation and biochemical characterization of Shigella organisms. These antisera are prepared in rabbits using reference strains according to recognized guidelines, and absorbed to remove cross-reactions. Shigella antisera are supplied in 2.0 ml dropper bottles, in a ready to use format.

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):	No
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?
51635	Shigella flexneri culture isolate antigen IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of antigens from Shigella flexneri bacteria isolated by culture from a clinical specimen.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
GNB	Antisera, All Types, Shigella 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d9e0652e-0a4c-4846-b98b-c8c74ce8b3ab
Public Version Date: December 28, 2022
Public Version Number: 1
DI Record Publish Date: December 20, 2022