ThinPrep Pap Test

Primary DI
15420045514683
Brand
ThinPrep Pap Test
Company
Hologic, Inc.
Model
ThinPrep Pap Test Filters
Published
2021-09-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MKQProcessor, cervical cytology slide, automated

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MKQProcessor, Cervical Cytology Slide, AutomatedUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P950039000
P950039028

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P950039000THINPREP(R) PROCESSOR, MODEL TP 2000Hologic, Inc.1996-05-20MKQ
P950039028THINPREP(R) PROCESSOR, MODEL TP 2000Hologic, Inc.1996-05-20MKQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
35420045514687PackageGS15In Commercial Distribution
25420045514680PrimaryGS10
15420045514683Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3542004551468735420045514687
2542004551468025420045514680
1542004551468315420045514683

GMDN Terms#

Term, Definition table
TermDefinition
Microscope slide maker IVDAn automated mains electricity (AC-powered) laboratory instrument intended to be used to prepare, transfer and/or fix blood, tissue or other clinical specimens onto microscope examination slides so they are suitable for subsequent staining and/or microscopic analysis. The device operates with minimal technician involvement and complete automation of all procedural steps.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)442-9892CustomerSupport@hologic.com

Regulatory Flags#

DUNS number
018925968
Device count
100
DM exempt
true
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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15420045500471ProcleixUltrio Plus HBV D-Probes3025762014-08-06
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Primary DI, Brand, Company table
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15420045514157ThinPrepHologic, Inc.MKQ2024-05-20
25420045514680ThinPrep Pap TestHologic, Inc.MKQ2021-09-29
15420045514652ThinPrep® Pap TestHologic, Inc.MKQ2021-09-17
15420045513945ThinPrep 5000 ProcessorHologic, Inc.MKQ2020-09-25
15420045513952ThinPrep 5000 ProcessorHologic, Inc.MKQ2020-09-25
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