FDA.reportPublic FDA data

BD Molecular LBC Sample Buffer Tubes

Primary DI
00382904439231
Brand
BD Molecular LBC Sample Buffer Tubes
Company
BECTON, DICKINSON AND COMPANY
Model
443923
Catalog number
443923
Device description
Molecular LBC Sample Buffer Tubes 48EA
Published
2024-02-23
Public version status
New
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
MKZDNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MKZDna Probe, Nucleic Acid Amplification, ChlamydiaMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182692000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182692000BD MAX CTGCTV2, BD MAX SystemBecton, Dickinson and Company2019-01-08OUY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30382904439232PrimaryGS10
00382904439231Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3038290443923230382904439232
00382904439231003829044392313829044392310382904439231

GMDN Terms#

Term, Definition table
TermDefinition
Cytology specimen container IVD, transport bufferA covered receptacle containing transport buffer solution intended to be used for the collection, preservation, and transport of a cytology specimen (e.g., oral, cervical, colonic) for in vitro diagnostic investigation [e.g., histopathological cervical cancer screening]. It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius33 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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
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
00382904439248BD Molecular Urine Transport KitBECTON, DICKINSON AND COMPANYMKZ2024-05-16
30382904402960BD Molecular Swab Sample Buffer TubesBECTON, DICKINSON AND COMPANYMKZ2024-02-26
00382904402969BD Molecular Swab Sample Buffer TubesBECTON, DICKINSON AND COMPANYMKZ2024-02-26
30382904439232BD Molecular LBC Sample Buffer TubesBECTON, DICKINSON AND COMPANYMKZ2024-02-23
15420045511880Aptima®Hologic, Inc.MKZ2023-10-26
00884999051096Alinity mABBOTT MOLECULAR INC.MKZ2023-09-14
00810031720064Visby Medical Sexual Health TestVisby Medical, Inc.MKZ2023-04-19
00810031720071Visby Medical Power Adapter, Right AngleVisby Medical, Inc.MKZ2023-04-19
15420045514966APTIMAHologic, Inc.MKZ2022-07-28
15420045514973APTIMAHologic, Inc.MKZ2022-07-28
00382904439040BD CTGCTV2 for BD MAX™ SystemBECTON, DICKINSON AND COMPANYMKZ2022-07-14
00382904439897BD COR™ MXBECTON, DICKINSON AND COMPANYMKZ2022-06-16
00382904439798BD CTGCTV2BECTON, DICKINSON AND COMPANYMKZ2022-06-08
00884999048898Alinity mABBOTT MOLECULAR INC.MKZ2022-05-18
00884999047686Alinity mABBOTT MOLECULAR INC.MKZ2022-05-18
00884999047693Alinity mABBOTT MOLECULAR INC.MKZ2022-05-18
00884999049314Alinity mABBOTT MOLECULAR INC.MKZ2022-05-18
00810031720002Visby Medical Sexual Health Click TestVisby Medical, Inc.MKZ2021-09-15
00810031720033Visby Medical Power AdapterVisby Medical, Inc.MKZ2021-09-15
00810031720057Visby Medical Sexual Health Vaginal Specimen Collection Kit, 50 PackVisby Medical, Inc.MKZ2021-09-15
15420045512818APTIMAHologic, Inc.MKZ2020-06-24
15420045512825APTIMAHologic, Inc.MKZ2020-06-24
15420045512832Aptima Combo 2®Hologic, Inc.MKZ2020-06-16
15420045512849Aptima Combo 2®Hologic, Inc.MKZ2020-06-16
15420045512894Aptima Combo 2®Hologic, Inc.MKZ2020-06-16
15420045512900Aptima Combo 2®Hologic, Inc.MKZ2020-06-16
00382904411268BD ProbeTec™ Chlamydia trachomatis (CT) Qx Amplified DNA AssayBECTON, DICKINSON AND COMPANYMKZ2018-05-25
00382904429591BD ProbeTec™ Chlamydia trachomatis Qx Assay Gray Amp Reagent PackBECTON, DICKINSON AND COMPANYMKZ2018-05-25
00382904429706BD MAX™ CT/GC/TVBECTON, DICKINSON AND COMPANYMKZ2018-05-25
00875197005776cobas CTNG Qualitative nucleic acid test for use on the cobas 6800/8800 SystemsRoche Molecular Systems, Inc.MKZ2018-04-26