FDA.reportPublic FDA data

BD BBL™ VDRL Antigen

Primary DI
00382902407652
Brand
BD BBL™ VDRL Antigen
Company
BECTON, DICKINSON AND COMPANY
Model
240765
Catalog number
240765
Device description
BD BBL™ VDRL Antigen
Published
2016-05-19
Public version status
Update
Distribution status
Not 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
GMQANTIGENS, NONTREPONEMAL, ALL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GMQAntigens, Nontreponemal, AllMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382902407652PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382902407652003829024076523829024076520382902407652

GMDN Terms#

Term, Definition table
TermDefinition
Treponema pallidum reagin antibody IVD, kit, agglutinationA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of non-specific reagin antibodies that are produced in response to infection with Treponema pallidum bacteria, in a clinical specimen using an agglutination method [for example Rapid Plasma Reagin (RPR) test or Venereal Disease Research Laboratory (VDRL) test]. The assay is designed to detect infection with Treponema pallidum, the bacteria associated with syphilis.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Fragile, handle with care
Special Storage Condition, Specify00P403 – Store in a well-ventilated place.
Special Storage Condition, Specify00This way up
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
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00382905167065BD Intelliport5167065167062020-09-30
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850021758233RPR Carbon AntigenKSL Biomedical, Inc.GMQ2026-04-13
B350GSD011600DIL0GSD RPR DiluentGold Standard Diagnostics CorporationGMQ2025-10-16
B350GSD0116005C0Gold Standard Diagnostics Rapid Plasma Reagin (RPR) Test System-5CGold Standard Diagnostics CorporationGMQ2024-12-06
B350GSD051600MW0Microtiterplates (5)Gold Standard Diagnostics CorporationGMQ2024-10-22
00816057021666ASI EvolutionARLINGTON SCIENTIFIC, INC.GMQ2023-12-19
00816057021673ASI RPR Test for Syphilis for Use on the ASI EvolutionARLINGTON SCIENTIFIC, INC.GMQ2023-12-19
00816057021680ASI RPR Test for Syphilis for Use on the ASI EvolutionARLINGTON SCIENTIFIC, INC.GMQ2023-12-19
00816057021697ASI RPR Automated Control Set ARLINGTON SCIENTIFIC, INC.GMQ2023-12-19
00816057021703ASI RPR Automated Control Set ARLINGTON SCIENTIFIC, INC.GMQ2023-12-19
00816057021710ASI Evolution RPR Titration DiluentARLINGTON SCIENTIFIC, INC.GMQ2023-12-19
B35000400R0AIX1000 AnalyzerGold Standard Diagnostics CorporationGMQ2023-10-31
B350GSD011600DYE0AIX1000 Performance Check Dye KitGold Standard Diagnostics CorporationGMQ2023-09-13
B350GSD051600NC0RPR Non-Reactive ControlGold Standard Diagnostics CorporationGMQ2023-09-13
B350GSD051600PC0RPR Reactive ControlGold Standard Diagnostics CorporationGMQ2023-09-13
B350GSD051600W0GSD RPR Microtiterplate - 5 pack sleeveGold Standard Diagnostics CorporationGMQ2022-11-25
B350GSD1600WCASE0MicrotiterplatesGold Standard Diagnostics CorporationGMQ2022-10-14
00894175000077AccuDiag ™ Diagnostic Automation, Inc.GMQ2021-08-11
10673486000689TECO DIAGNOSTICSTECO DIAGNOSTICSGMQ2021-08-11
10673486000696TECO DIAGNOSTICSTECO DIAGNOSTICSGMQ2021-08-11
03610522004980BioPlex 2200BIO-RAD LABORATORIES, INC.GMQ2018-02-05
03610522015597BioPlex 2200BIO-RAD LABORATORIES, INC.GMQ2018-02-05
03610520138267BioPlex 2200BIO-RAD LABORATORIES, INC.GMQ2017-07-25
03610520992692BioPlex 2200BIO-RAD LABORATORIES, INC.GMQ2017-07-25
03610520653012BioPlex 2200BIO-RAD LABORATORIES, INC.GMQ2017-07-25
10722355001767Detector RPRImmunostics Company, IncGMQ2016-12-03
10722355001774Detector RPRImmunostics Company, IncGMQ2016-12-03
10722355001781Detector RPRImmunostics Company, IncGMQ2016-12-03
10722355001798Detector RPRImmunostics Company, IncGMQ2016-12-03
10722355001804Detector RPRImmunostics Company, IncGMQ2016-12-03
10722355001811Detector RPRImmunostics Company, IncGMQ2016-12-03