FDA.reportPublic FDA data

BD Dispenstirs™ Device

Primary DI
30382902729052
Brand
BD Dispenstirs™ Device
Company
BECTON, DICKINSON AND COMPANY
Model
272905
Catalog number
272905
Device description
BD Dispenstirs™ Device, 0.05 mL volume
Published
2016-05-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GMQANTIGENS, NONTREPONEMAL, ALL
LXGEQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GMQAntigens, Nontreponemal, AllMicrobiology2
LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30382902729052PrimaryGS10
00382902729051Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3038290272905230382902729052
00382902729051003829027290513829027290510382902729051

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, Specify00Room Temperature

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
122561087
Device count
500
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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10382902212673BD BBL™ Chocolate II Agar (GC II Agar with Hemoglobin and IsoVitaleX™)2212672212672016-12-21
30382903836483Nexiva3836483836482026-02-17
30382903810124Insyte Autoguard3810123810122026-02-13
30382903810230Insyte Autoguard3810233810232026-02-13
30382903810247Insyte Autoguard3810243810242026-02-13
30382903810339Insyte Autoguard3810333810332026-02-13
30382903810346Insyte Autoguard3810343810342026-02-13
30382903810377Insyte Autoguard3810373810372026-02-13
30382903810445Insyte Autoguard3810443810442026-02-13
30382903810476Insyte Autoguard3810473810472026-02-13
50382903810548Insyte Autoguard3810543810542026-02-13
50382903810579Insyte Autoguard3810573810572026-02-13
30382903818335Insyte Autoguard3818333818332026-02-13
30382903818373Insyte Autoguard3818373818372026-02-13
50382903818476Insyte Autoguard3818473818472026-02-13
30382903818540Insyte Autoguard3818543818542026-02-13
50382903818575Insyte Autoguard3818573818572026-02-13
50382903818674Insyte Autoguard3818673818672026-02-13
30382903819127Insyte Autoguard3819123819122026-02-13

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04250317554611PrecolumnChromsystems Instruments + Chemicals GmbHLXG2026-01-22
04250317555281PrefilterChromsystems Instruments + Chemicals GmbHLXG2026-01-22
04250317558022PrefilterChromsystems Instruments + Chemicals GmbHLXG2026-01-22
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17290020288049CellSHILEDEQUASHIELD MEDICAL LTDLXG2025-07-20
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