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
50382905167015BD Intelliport5167015167012020-09-30
00382905167508BD Intelliport5167505167502020-09-30
00382905168031BD Intelliport System5168035168032024-06-07
00382905168000BD Intelliport System5168005168002024-06-07
00382905167041BD Intelliport5167045167042020-09-30
00382904453497BD BACTEC™ FXI Culture System Workflow Module4453494453492026-06-02
00382904453503BD BACTEC™ FXI Culture System Analyzer Module4453504453502026-06-02
30382903686545BD Vacutainer® Safety-Lok™ Blood Collection Set Pre-Attached Holder3686543686542024-03-25
00382904003739BD Whitacre Spinal4003734003732023-09-02
00382904003821BD Whitacre Spinal4003824003822023-09-02
30382903666042BD MiniDraw™ SST™ Capillary Blood Collection Tube3666043666042024-06-06
30382903666134BD MiniDraw™ Finger Sleeve, Small3666133666132024-06-06
30382903666141BD MiniDraw™ Finger Sleeve, Medium3666143666142024-06-06
30382903666158BD MiniDraw™ Finger Sleeve, Large3666153666152024-06-06
30382903666165BD MiniDraw™ Finger Sleeve, Extra-Large3666163666162024-06-06
30382903666172BD MiniDraw™ Finger Sizing Tool3666173666172024-06-06
00382904003715BD Whitacre Spinal4003714003712023-09-02
00382904003722BD Whitacre Spinal4003724003722023-09-02
00885403522270Swan-Ganz131F7P2026-05-30
00885403522348SWAN-GANZ CCOMBO V777F82026-05-30

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