BD BBL™ Staphyloslide™ Latex Test Kit 240916

GUDID 00382902409168

BD BBL™ Staphyloslide™ Latex Test Kit 500 tests Contains: 5 x 5.0 mL Test Latex, 2 x 6.5 mL Control Latex

BECTON, DICKINSON AND COMPANY

Staphylococcus aureus culture isolate antigen IVD, kit, agglutination Staphylococcus aureus culture isolate antigen IVD, kit, agglutination
Primary Device ID00382902409168
NIH Device Record Keybdc5e101-a781-43a0-b5aa-7b60972bfe97
Commercial Distribution StatusIn Commercial Distribution
Brand NameBD BBL™ Staphyloslide™ Latex Test Kit
Version Model Number240916
Catalog Number240916
Company DUNS122561087
Company NameBECTON, DICKINSON AND COMPANY
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100382902409168 [Primary]

FDA Product Code

GTNANTISERA, FLUORESCENT, ALL TYPES, STAPHYLOCOCCUS SPP.

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-06-25
Device Publish Date2018-05-25

On-Brand Devices [BD BBL™ Staphyloslide™ Latex Test Kit]

00382902409168BD BBL™ Staphyloslide™ Latex Test Kit 500 tests Contains: 5 x 5.0 mL Test Latex, 2 x
00382902409151BD BBL™ Staphyloslide™ Latex Test Kit 100 tests Contains: 2 x 2.5 mL Test Latex, 1 x

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.