FDA.reportPublic FDA data

Epredia

Primary DI
05051663625302
Brand
Epredia
Company
SHANDON DIAGNOSTICS LIMITED
Model
EZ Cytofunnel
Catalog number
A78710015
Device description
Cytospin 4 Cytocentrifuge - Accessory
Published
2024-02-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
IFBCytocentrifuge

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IFBCytocentrifugePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05051663625302PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05051663625302050516636253025051663625302

GMDN Terms#

Term, Definition table
TermDefinition
Cytological centrifuge IVDAn electrically-powered device intended to be used in a clinical laboratory setting to separate the cellular components of suspensions in a clinical specimen through centrifugal force for subsequent cytological analysis. It is typically a compact unit with an electric motor, a vertical shaft, and a special horizontal rotor attached that enables cells to be separated from a liquid suspension and deposited directly onto a microscope slide for microscopic examination.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
219103512
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05051663626071EprediaLaser Embedding Cassettes - White110-01-10LMI2026-03-11
05051663626927EprediaLaser Embedding Cassettes - White110-01-10LMI2026-03-11
05051663011501EprediaAvantik QS12 Cryostat-UK956660-UK2025-11-07
05051663011518EprediaAvantik QS12 UV Cryostat-UK956661-UK2025-11-07
05051663011112EprediaHM525 NX Cryostat-UK956640-UK 2025-08-26
05051663011129EprediaHM525 NX UV Cryostat-UK956641-UK2025-08-26
05051663010580EprediaHM 355S Rotary Microtome-UK905200-UK2025-06-11
05051663010467EprediaE1000 Dx Digital Pathology Solution A85200002 2025-03-10
05051663518581EprediaRevos Chamber Filter Assembly KitA841101552024-06-13
05051663518598EprediaChamber Filter Tool KitA841101562024-06-13
05051663518604EprediaNose Cone Extraction Tool KitA841101572024-06-13
05051663010528EprediaHM 325 Rotary Microtome (UK made)902100-UK2024-05-10
05051663010559EprediaHM 340E Rotary Microtome (UK made)905190-UK 2024-05-10
05051663517362EprediaSLIP HOPPER 24x40mm #1.5A792100502024-02-16
05051663517379EprediaSLIP HOPPER 24x50mm #1.5A792100512024-02-16
05051663517386EprediaSLIP HOPPER 24x55mm #1.5A792100522024-02-16
05051663517393EprediaBasket Stand CompleteA792100562024-02-16
05051663517423EprediaSakura DRS2000 Basket (5)A792100662024-02-16
05051663517430EprediaSakura DRS2000 Basket (5)A792100672024-02-16
05051663517447EprediaSakura DRS2000 Basket (5)A792100682024-02-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00673693226967EprediaRICHARD-ALLAN SCIENTIFIC COMPANYIFB2024-10-21
00673693226943EprediaRICHARD-ALLAN SCIENTIFIC COMPANYIFB2024-10-18
00673693241731EprediaRICHARD-ALLAN SCIENTIFIC COMPANYIFB2024-10-18
00673693220118EprediaRICHARD-ALLAN SCIENTIFIC COMPANYIFB2024-07-31
00673693220163EprediaRICHARD-ALLAN SCIENTIFIC COMPANYIFB2024-07-31
00673693220200EprediaRICHARD-ALLAN SCIENTIFIC COMPANYIFB2024-07-31
00673693220101EprediaRICHARD-ALLAN SCIENTIFIC COMPANYIFB2024-07-30
00673693229913EprediaRICHARD-ALLAN SCIENTIFIC COMPANYIFB2024-07-30
00673693229920EprediaRICHARD-ALLAN SCIENTIFIC COMPANYIFB2024-07-30
00673693217880EprediaRICHARD-ALLAN SCIENTIFIC COMPANYIFB2024-07-25
00673693217897EprediaRICHARD-ALLAN SCIENTIFIC COMPANYIFB2024-07-25
00673693222174EprediaRICHARD-ALLAN SCIENTIFIC COMPANYIFB2024-07-25
00673693227025EprediaRICHARD-ALLAN SCIENTIFIC COMPANYIFB2024-07-25
00673693227032EprediaRICHARD-ALLAN SCIENTIFIC COMPANYIFB2024-07-25
00673693227049EprediaRICHARD-ALLAN SCIENTIFIC COMPANYIFB2024-07-25
00673693227056EprediaRICHARD-ALLAN SCIENTIFIC COMPANYIFB2024-07-25
00673693227063EprediaRICHARD-ALLAN SCIENTIFIC COMPANYIFB2024-07-25
05051663517928EprediaSHANDON DIAGNOSTICS LIMITEDIFB2024-02-16
05051663518345EprediaSHANDON DIAGNOSTICS LIMITEDIFB2024-02-16
05051663625265EprediaSHANDON DIAGNOSTICS LIMITEDIFB2024-02-16
05051663625272EprediaSHANDON DIAGNOSTICS LIMITEDIFB2024-02-16
05051663625289EprediaSHANDON DIAGNOSTICS LIMITEDIFB2024-02-16
05051663625319EprediaSHANDON DIAGNOSTICS LIMITEDIFB2024-02-16
05051663625326EprediaSHANDON DIAGNOSTICS LIMITEDIFB2024-02-16
05051663625340EprediaSHANDON DIAGNOSTICS LIMITEDIFB2024-02-16
07898027907630CELLPRESERV KOLPLASTKolplast C IIFB2023-11-29
03661540302640Cytopro Single Sample Chamber Caps, pack of 48ELITECHGROUP INC.IFB2023-08-14
03661540302664Cytopro Cytopad, slow, tan, package of 100ELITECHGROUP INC.IFB2023-08-14
03661540302671Sample Chambers w/ fast, white Cytopads, caps, pk48ELITECHGROUP INC.IFB2023-08-14
03661540302688Sample Chambers w/Slow, Tan Cytopads, Caps, 48pk.ELITECHGROUP INC.IFB2023-08-14