FDA.reportPublic FDA data

BD BBL™ TB Auramine-Rhodamine T

Primary DI
30382902125151
Brand
BD BBL™ TB Auramine-Rhodamine T
Company
BECTON, DICKINSON AND COMPANY
Model
212515
Catalog number
212515
Device description
BD BBL™ TB Auramine-Rhodamine T, 4 x 250 mL
Published
2018-05-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KJKAURAMINE O

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KJKAuramine OHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30382902125151PackageGS14In Commercial Distribution
00382902125150PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3038290212515130382902125151
00382902125150003829021251503829021251500382902125150

GMDN Terms#

Term, Definition table
TermDefinition
Biological stain kit IVDA collection of chemical agents, dyes and/or solutions intended for the artificial colouration of specific target tissue structures, intra/extracellular elements and/or infectious microorganisms in a clinical specimen for subsequent visualization, examination, identification and/or differentiation.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume250Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)638-8663Technical_services@bd.com

Regulatory Flags#

DUNS number
122561087
Device count
4
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00382906718167Horizon6718166718162026-09-24
00382906718174Horizon6718176718172026-09-24
00382906718181Horizon6718186718182026-09-24
00382906718198Horizon6718196718192026-09-24
00382906718204Horizon6718206718202026-09-24
00382906718211Horizon6718216718212026-09-24
00382906718235Horizon6718236718232026-09-24
00382906718242Horizon6718246718242026-09-24
00382906718259Horizon6718256718252026-09-24
00382906718266Horizon6718266718262026-09-24
00382906718273Horizon6718276718272026-09-24
00382906718280Horizon6718286718282026-09-24
00382906718310Horizon6718316718312026-09-24
00382906718327Horizon6718326718322026-09-24
00382906718334Horizon6718336718332026-09-24
00382906718341Horizon6718346718342026-09-24
00382906718358Not Applicable6718356718352026-09-24
00382906718365Horizon6718366718362026-09-24
00382906718372Horizon6718376718372026-09-24
00382906718389Horizon6718386718382026-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816085021560Alpha-Tec SystemsAlpha-TEC Systems, Inc.KJK2022-08-11
00816085021577Alpha-Tec SystemsAlpha-TEC Systems, Inc.KJK2022-08-11
00816085021638Alpha-Tec SystemsAlpha-TEC Systems, Inc.KJK2022-08-11
00816085021645Alpha-Tec SystemsAlpha-TEC Systems, Inc.KJK2022-08-11
00816085021652Alpha-Tec SystemsAlpha-TEC Systems, Inc.KJK2022-08-11
00816085023519Alpha-Tec SystemsAlpha-TEC Systems, Inc.KJK2022-08-08
00816085023571Alpha-Tec SystemsAlpha-TEC Systems, Inc.KJK2022-08-08
00816085020778Alpha-Tec SystemsAlpha-TEC Systems, Inc.KJK2022-08-08
00816085020808Alpha-Tec SystemsAlpha-TEC Systems, Inc.KJK2022-08-08
00816085023502Alpha-Tec SystemsAlpha-TEC Systems, Inc.KJK2022-08-08
00816085023564Alpha-Tec SystemsAlpha-TEC Systems, Inc.KJK2022-08-08
30382902125144BD BBL™ TB Auramine MBECTON, DICKINSON AND COMPANYKJK2018-05-25