FDA.reportPublic FDA data

BD MAX™ UVE Sample Buffer Tubes

Primary DI
30382904434206
Brand
BD MAX™ UVE Sample Buffer Tubes
Company
BECTON, DICKINSON AND COMPANY
Model
443420
Catalog number
443420
Device description
BD MAX ™ UVE Sample Buffer Tubes Contains: 48 x 1.5 mL Sample Buffer Tubes
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
30382904434206PrimaryGS10
00382904434205Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3038290443420630382904434206
00382904434205003829044342053829044342050382904434205

GMDN Terms#

Term, Definition table
TermDefinition
Multiple sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple types of microorganisms associated with sexually transmitted infections (STI), in a clinical specimen, using a nucleic acid technique (NAT). Microorganisms detected may include (but are not limited to) Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma species, Ureaplasma species, Treponema pallidum, Trichomonas vaginalis, herpes simplex virus 1 and/or herpes simplex virus 2 (HSV1 & 2).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume1.5Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
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
48
Lot or batch
true
Expiration date on label
true

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30382903666172BD MiniDraw™ Finger Sizing Tool3666173666172024-06-06
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00382904003722BD Whitacre Spinal4003724003722023-09-02
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Primary DI, Brand, Company table
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