AccessGUDID - DEVICE: BD BBL™ Streptocard™ Enzyme Test Latex B (00382902409571)

GUDID

Device Identifier (DI) Information

Brand Name: BD BBL™ Streptocard™ Enzyme Test Latex B
Version or Model: 240957
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 240957
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 00382902409571
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 122561087 *Terms of Use

Device Description: BD BBL™ Streptocard™ Enzyme Test Latex B, one 2.5 mL bottle

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):	Yes
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?
43586	Beta-haemolytic Streptococcus serological grouping IVD, kit, agglutination	A collection of reagents and other associated materials intended to be used to determine the serological group (or Lancefield group) of beta-haemolytic streptococci isolated from a clinical specimen by culture, using an agglutination method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GTZ	ANTISERA, 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
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 2.5 Milliliter

Device Record Status

Public Device Record Key: 79124e8f-8ae9-4be6-8e26-dafb252108a1
Public Version Date: July 10, 2024
Public Version Number: 2
DI Record Publish Date: May 25, 2018