BD BBL™ Streptocard™ Enzyme Latex Kit

Basic Information

• Brand Name: BD BBL™ Streptocard™ Enzyme Latex Kit
• Primary DI: 00382902409182
• Version / Model: 240918
• Catalog Number: 240918
• Company Name: BECTON, DICKINSON AND COMPANY
• Labeler DUNS: 122561087
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-05-25
• Public Version: 1
• Public Version Date: 2018-06-25
• Public Version Status: New
• Public Device Record Key: 074c006b-dec9-4ea0-9a7d-bb4b70bd60af

Device Description

BD BBL ™ Streptocard™ Enzyme Latex Kit Contains: Test Latex A,B,C,D,F and G (1 x 2.5 mL), Extraction Enzyme (1 x 22 mL), Control + (1 x 2.5 Ml)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GTZ	ANTISERA, ALL GROUPS, STREPTOCOCCUS SPP.	Microbiology	866.3740	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00382902409182	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius