FDA.reportPublic FDA data

Cellient®

Primary DI
15420045508569
Brand
Cellient®
Company
Hologic, Inc.
Model
Cellient Processor
Catalog number
71959-001
Device description
Processor for use in preparation of cell blocks from cellular material and tissue fragments in PreservCyt®.
Published
2017-10-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IDTAPPARATUS, MELTING POINT, PARAFFIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IDTApparatus, Melting Point, ParaffinPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15420045508569PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1542004550856915420045508569

GMDN Terms#

Term, Definition table
TermDefinition
Tissue processor IVD, automatedA mains electricity (AC-powered) laboratory instrument intended to be used for the processing of clinical tissue specimens [e.g., fixation (encapsulation in paraffin wax), dehydration, infiltration] in preparation for subsequent cytological or histological examination. The device may be a single unit or modular assembly. The device operates with minimal technician involvement and complete automation of all procedural steps.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature16 Degrees Celsius32 Degrees Celsius
Storage Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-28 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
018925968
Device count
1
DM exempt
true
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15420045518452DIGITAL DIAGNOSTICS SYSTEMDIGITAL CYTOLOGY IMAGERRM-ASY-185882026-10-19
15420045518933DIGITAL DIAGNOSTICS SYSTEMDIGITAL CYTOLOGY IMAGERRM-ASY-185892026-10-19
00850346007030CoolSeal™ TrinityCSL-TR105-30CSL-TR105-302020-10-13
00850346007047CoolSeal™ TrinityCSL-TR105-37CSL-TR105-372020-10-13
00850346007061CoolSeal™ TrinityCSL-TR105-44CSL-TR105-442020-10-13
00850346007092CoolSeal™ RevealCSL-RV105-10CSL-RV105-102021-05-19
00850346007085CoolSeal™ MiniCSL-MN103-20CSL-MN103-202020-10-13
00850346007023CoolSeal™ GeneratorCSL-200-50CSL-200-502020-10-13
15420045515796EnvisionEnvision System Software LicenseCMP-019182026-10-09
15420045515802EnvisionEnvision Tomosynthesis LicenseCMP-029192026-10-09
15420045515864EnvisionEnvision Tomo Synthesized 2D LicenseCMP-019212026-10-09
15420045515871EnvisionEnvision 3DQorum LicenseCMP-019222026-10-09
15420045515895EnvisionEnvision SmartCurve Paddle LicenseCMP-019242026-10-09
15420045517462EnvisionENV-SYS-STDENV-SYS-STD2026-10-09
15420045517479EnvisionENV-SYS-STD-NSENV-SYS-STD-NS2026-10-09
05420045503888SecurMarkSMARK-U-SS1SMARK-U-SS12015-09-04
05420045503895SecurMarkSMARK-U-SS2SMARK-U-SS22015-09-04
05420045503901SecurMarkSMARK-U-SS3SMARK-U-SS32015-09-04
15420045511859Unifi WorkspaceUnifi Workspace V1.02019-08-09
15420045515307Acessa ProVu System710071002023-05-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15420045513938Cellient®Hologic, Inc.IDT2022-12-14
15420045508576Cellient®Hologic, Inc.IDT2017-10-12