FDA.reportPublic FDA data

BD ProbeTec™ Chlamydia trachomatis Qx Assay Gray Amp Reagent Pack

Primary DI
00382904429591
Brand
BD ProbeTec™ Chlamydia trachomatis Qx Assay Gray Amp Reagent Pack
Company
BECTON, DICKINSON AND COMPANY
Model
442959
Catalog number
442959
Device description
BD ProbeTec™ Chlamydia trachomatis Qx Assay Gray Amp Reagent Pack
Published
2018-05-25
Public version status
Update
Distribution status
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
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
K140446000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140446000BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAYBecton, Dickinson & CO2014-05-20MKZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382904429591PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382904429591003829044295913829044295910382904429591

GMDN Terms#

Term, Definition table
TermDefinition
Chlamydia trachomatis 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 Chlamydia trachomatis bacteria in a clinical specimen, using a nucleic acid technique (NAT).

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
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00885403522386Swan-Ganz831F75P2026-05-30
00885403523819VAMPVMP400VMP4002026-05-30
00885403524618TruWave, VAMP PlusPXVP2284AT3PXVP2284AT32026-05-30
00885403524717TruWave, VAMP PlusPXVP0566PXVP05662026-05-30
00885403524779TruWave, VAMP PlusPXVP2272PXVP22722026-05-30

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
00382904439231BD 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
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