FDA.reportPublic FDA data

BD ProbeTec™ Qx Collection Kit for Endocervical or Lesion Specimens

Primary DI
00382904413576
Brand
BD ProbeTec™ Qx Collection Kit for Endocervical or Lesion Specimens
Company
BECTON, DICKINSON AND COMPANY
Model
441357
Catalog number
441357
Device description
BD ProbeTec™ Qx Collection Kit for Endocervical or Lesion Specimens Contains: 100 each sterile polyester-tipped cleaning swab, sterile polyurethane-tipped collection swab, Q? Swab Diluent tube
Published
2016-05-19
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
LSLDNA-REAGENTS, NEISSERIA

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K081825000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081825000BD PROBETEC NEISSERIA GONORRHOEAE (GC) Q AMPLIFIED DNA ASSAYBecton, Dickinson & CO2008-12-11LSL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30382904413577PackageGS1100In Commercial Distribution
00382904413576PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3038290441357730382904413577
00382904413576003829044135763829044135760382904413576

GMDN Terms#

Term, Definition table
TermDefinition
Urogenital specimen collection kit IVD, clinicalA collection of devices intended exclusively for professional use for the collection, and preservation and/or transport, of cellular and/or other material collected from the endocervix, vagina, and other male/female lower urogenital area (e.g., urethra) for in vitro diagnostic investigation [e.g., microbiological culture, histopathological cervical cancer screening]. The kit consists of a specimen sampling/collection tool(s) [e.g., swab, brush, spatula], and a covered receptacle with or without an additive/medium (e.g., preservative solution, Amies/Stuart transport medium); initial preparation/fixation/preservation materials may also be included in the kit. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00This way up
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

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00885403523734VAMP48VMP18448VMP1842026-07-31
00885403524281TruWave, VAMP PlusPXVP1087PXVP10872026-07-31
00885403524694TruWave, VAMP PlusPXVP0550PXVP05502026-07-31
00885403524922TruWavePX266CPX266C2026-07-31
00885403525066TruWave, VAMPPXAVMPPXAVMP2026-07-31
00885403525547TruWave, VAMPPXAVMP3PXAVMP32026-07-31
00885403525608TruWave, VAMPPXVMP172AT3PXVMP172AT32026-07-31
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00885403529651Acumen IQ CuffAIQCMAIQCM2026-07-31
00885403530404Fogarty120404F120404F2026-07-31
00885403530411Fogarty120602F120602F2026-07-31
00885403530428Fogarty120803F120803F2026-07-31
00885403530442Fogarty120804F120804F2026-07-31
00885403530466Fogarty120805F120805F2026-07-31
00885403530565Fogarty12TLW805F3512TLW805F352026-07-31

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