FDA.reportPublic FDA data

BD ProbeTec ET CT/GC Amplified DNA Assay Endocervical Collection & Transport Kit

Primary DI
30382904404766
Brand
BD ProbeTec ET CT/GC Amplified DNA Assay Endocervical Collection & Transport Kit
Company
BECTON, DICKINSON AND COMPANY
Model
440476
Catalog number
440476
Device description
BD ProbeTec™ ET Chlamydia trachomatis/Neisseria gonorrhoeae (CT/GC) Amplified DNA Assay Endocervical Specimen Collection and DRY TRANSPORT Kit Contains: 100 each polyurethane-tipped swab in tubes, rayon-tipped cleaning swabs
Published
2016-07-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LSLDNA-REAGENTS, NEISSERIA

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LSLDna-Reagents, NeisseriaMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K984631000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K984631000BDPROBETEC ET CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE AMPLIFIED DNA ASSAYBecton Dickinson Microbiology Systems1999-11-04LSL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30382904404766PackageGS1100In Commercial Distribution
00382904404765PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3038290440476630382904404766
00382904404765003829044047653829044047650382904404765

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
Storage Environment Temperature15 Degrees Celsius30 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
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

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00885403533160TruWave Reusable Cable64EKH64EKH2026-09-18
00885403533610TruWave Reusable Cable70ANHS70ANHS2026-09-18
00885403533634Pressure Slave Cable70ANS70ANS2026-09-18
00885403533641Cable COO Catheter Interface70CC270CC22026-09-18
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00885403543305TruWavePX21S162PX21S1622026-09-18
00885403543312TruWavePX6D162PX6D1622026-09-18
00885403543428TruWavePX6T162PX6T1622026-09-18
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00885403543466TruWavePX7D162PX7D1622026-09-18

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