FDA.reportPublic FDA data

BD MAX™ UVE Specimen Collection Kit

Primary DI
30382904433766
Brand
BD MAX™ UVE Specimen Collection Kit
Company
BECTON, DICKINSON AND COMPANY
Model
443376
Catalog number
443376
Device description
BD MAX UVE Specimen Collection Kit
Published
2016-10-17
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
LSLDNA-REAGENTS, NEISSERIA
MKZDNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA
OUYTrichomonas vaginalis nucleic acid amplification test system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LSLDna-Reagents, NeisseriaMicrobiology2
MKZDna Probe, Nucleic Acid Amplification, ChlamydiaMicrobiology1
OUYTrichomonas Vaginalis Nucleic Acid Amplification Test SystemImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151589000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151589000BD MAX CT/GC/TV, BD MAX INSTRUMENTBecton, Dickinson and Company2016-09-06OUY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30382904433766PrimaryGS10
00382904433765Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3038290443376630382904433766
00382904433765003829044337653829044337650382904433765

GMDN Terms#

Term, Definition table
TermDefinition
Urogenital specimen transport medium collection kitA collection of sterile devices intended to be used for the collection, preservation, and transport of cellular and/or other material collected from the endocervix, vagina, and male/female urogenital area (e.g., urethra) for investigation by in vitro diagnostic procedures [e.g., nucleic acid technique (NAT), microbiological culture, histopathological cancer screening]. It includes a specimen collection tool(s) [e.g., swab, brush, spatula], and a covered plastic receptacle containing a transport medium (e.g., cell or nucleic acid preservation solution, microbiological medium). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Fragile, handle with care
Special Storage Condition, Specify00Peel here
Special Storage Condition, Specify00This way up
Storage Environment Temperature2 Degrees Celsius25 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
100
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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30382903666134BD MiniDraw™ Finger Sleeve, Small3666133666132024-06-06
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30382903666158BD MiniDraw™ Finger Sleeve, Large3666153666152024-06-06
30382903666165BD MiniDraw™ Finger Sleeve, Extra-Large3666163666162024-06-06
30382903666172BD MiniDraw™ Finger Sizing Tool3666173666172024-06-06
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00382904003722BD Whitacre Spinal4003724003722023-09-02
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00885403523819VAMPVMP400VMP4002026-05-30
00885403524618TruWave, VAMP PlusPXVP2284AT3PXVP2284AT32026-05-30
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Primary DI, Brand, Company table
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00382904439248BD Molecular Urine Transport KitBECTON, DICKINSON AND COMPANYMKZ2024-05-16
00382904439248BD Molecular Urine Transport KitBECTON, DICKINSON AND COMPANYOUY2024-05-16
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