FDA.reportPublic FDA data

digene® HC2 DNA Collection Device

Primary DI
14053228010354
Brand
digene® HC2 DNA Collection Device
Company
QIAGEN SCIENCES INC.
Model
1
Catalog number
619204
Published
2016-09-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
HHTSpatula, Cervical, Cytological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HHTSpatula, Cervical, CytologicalObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K971586000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K971586000DIGENE CERVICAL BRUSHDigene Corp.1997-09-19HHT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14053228010354PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1405322801035414053228010354

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008675485
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04053228047988IGRA Control Set16280222023-12-04
14053228015885QuantiFERON®-TB Gold Plus16224332017-10-02
14053228015892QuantiFERON®-TB Gold Plus16225362017-10-02
14053228015908QuantiFERON®-TB Gold Plus16235362017-10-02
14053228015915QuantiFERON®-TB Gold Plus16234332017-10-02
04053228002109QuantiFERON-TB Gold 2 Plate Kit159402012017-01-04
04053228002116QuantiFERON-TB Gold Reference Lab Pack159405012017-01-04
04053228015864QuantiFERON®-TB Gold Plus16221302017-10-02
04053228015871QuantiFERON®-TB Gold Plus16228322017-10-02
14053228033568QuantiFERON®-TB Gold Plus16225292019-12-18
14053228033575QuantiFERON®-TB Gold Plus16235292019-12-18
14053228002120QuantiFERON-TB Gold Blood Collection Tubes Dispenser Pack 159704032017-01-04
14053228002137QuantiFERON-TB Gold Blood Collection Tubes Dispenser Pack - High Altitude159704052017-01-04
14053228002144QuantiFERON-TB Gold Blood Collection Tubes1T059003012017-01-04
14053228002151QuantiFERON-TB Gold Blood Collection Tubes - High Altitude1T059005052017-01-04
04053228010777DML 300015000-000312016-12-21
14053228002014digene® Wash Buffer Concentrate 15100-000472017-01-04
04053228002000hc2 High-Risk HPV DNA Test15199-000162017-01-04
04053228002024hc2 HPV DNA Test15198-12202017-01-04
04053228002031hc2 High-Risk HPV DNA Test15199-12202017-01-04

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Primary DI, Brand, Company table
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