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Epredia

FDA UDI

Class I (US FDA UDI)

by Richard-Allan Scientific LLC

Identity

Trade Name
Epredia FDA UDI
Generic Name
Histology tissue cassette IVD, laboratory processing, single-use FDA UDI
Device Name
Cassettes are designed to contain incised tissue safely and securely for tissue processing, embedding, and sectioning. The cassettes are made of an acetyl copolymer designed to be solvent resistant during the normal tissue processing protocol. Specimen security can only be provided when Cassettes are used with approved and tested lids. Use of non-approved lids may lead to lid detachment during tissue processing. All cassettes with the exception of the Thinline and Fine Pore Cassette measure (H) 42.5mm, (W) 28.5mm, (D) 6.0mm. They are available in a range of colors. Differing in pore size and shape, there are three types available: Embedding, Biopsy, and Slotted. The choice of pore size is based on tissue type, size, and processing capabilities. The Histoscreen cassette utilizes a nylon mesh filter screen in the place of the typical pore sizes to be utilized for small, friable tissue that might escape the typical pore configurations during tissue processing. The Thinline and Fine Pore Cassettes have intermediate pore sizes between the Histoscreen and the traditional cassettes offering an injection moulded version with smaller pore size. Different coloured cassettes may be used to identify patient or tissue type. FDA UDI
Model / Reference
Embedding Cassettes without Lids FDA UDI
Description
Cassettes are designed to contain incised tissue safely and securely for tissue processing, embedding, and sectioning. The cassettes are made of an acetyl copolymer designed to be solvent resistant during the normal tissue processing protocol. Specimen security can only be provided when Cassettes are used with approved and tested lids. Use of non-approved lids may lead to lid detachment during tissue processing. All cassettes with the exception of the Thinline and Fine Pore Cassette measure (H) 42.5mm, (W) 28.5mm, (D) 6.0mm. They are available in a range of colors. Differing in pore size and shape, there are three types available: Embedding, Biopsy, and Slotted. The choice of pore size is based on tissue type, size, and processing capabilities. The Histoscreen cassette utilizes a nylon mesh filter screen in the place of the typical pore sizes to be utilized for small, friable tissue that might escape the typical pore configurations during tissue processing. The Thinline and Fine Pore Cassettes have intermediate pore sizes between the Histoscreen and the traditional cassettes offering an injection moulded version with smaller pore size. Different coloured cassettes may be used to identify patient or tissue type. FDA UDI

Identifiers

Catalog Number
B1000732PKCPL FDA UDI
Primary DI / UDI-DI
00673693744560 FDA UDI
FDA Product Code
IDZ FDA UDI
GMDN Term
Histology tissue cassette IVD, laboratory processing, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.3010 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Histology tissue cassette IVD, laboratory processing, single-use

Epredia by Richard-Allan Scientific LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Histology tissue cassette IVD, laboratory processing, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Richard-Allan Scientific LLC

Sources (1)

  • FDA UDI 53e961fc-38db-4ce5-966f-aa0aba9430aa 34 fields · synced Jun 8, 2026