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Device Explorer · FDA GUDID · GMDN 62970

Histology tissue cassette IVD, laboratory processing, single-use

A small device intended to be used in the laboratory to support/contain clinical tissue specimens (e.g., biopsy samples) to facilitate specimen processing [e.g., fixation (encapsulation in paraffin wax), dehydration, infiltration] in preparation for subsequent

US‑registered devices2,121in commercial distribution
Companies12labelers on GUDID
Single‑use99%of device records
Sterile0%labelled sterile
Prescription0%Rx‑only share
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Share of device records

Simport Scientific Inc.1,26460%
Richard-Allan Scientific Company33416%
Leica Biosystems Richmond, Inc.25912%
Sakura Finetek U.S.A., Inc.1487%
Caplugs512%
Globe Scientific Inc.281%
Grainger International, Inc.151%
Dynarex Corporation100%

Top labelers

CompanyDevicesShare
Simport Scientific Inc.1,26460%
Richard-Allan Scientific Company33416%
Leica Biosystems Richmond, Inc.25912%
Sakura Finetek U.S.A., Inc.1487%
Caplugs512%
Globe Scientific Inc.281%
Grainger International, Inc.151%
Dynarex Corporation100%
Typenex Medical Llc60%
Dakewe (Shenzhen) Medical Equipment Co., Ltd.40%
Shandon Diagnostics Limited10%
Hologic, Inc.10%

Company = labeler of record on GUDID. 12 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Embedding CassetteEprediaLabChoice Embedding Cassettes, Hindged Lid, WhitLabChoice Embedding Cassettes, Hindged Lid, WhitLabChoice Embedding Cassettes, Attached Lid, WhiLabChoice Embedding Cassettes, Attached Lid, WhiLabChoice Disposable Base Molds, Neutral, 25 x 4LabChoice Disposable Base Mold, Neutral, 25 x 32LabChoice Disposable Base Molds, Neutral, 25 x 2LabChoice Disposable Base Molds, Neutral, 17 x 1LabChoice Embedding Cassettes, Histology, UnasseLabChoice Embedding Cassettes, Biopsy, UnassemblGlobe ScientificDisposable Base MoldCaplugs/EvergreenHisto-Tek®

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
IDZCassettes, Tissue403
IDZCASSETTES, TISSUE398
KETFILTERS, CELL COLLECTION, TISSUE PROCESSING51
KERContainer, Embedding4
KETFilters, Cell Collection, Tissue Processing1
KDTCONTAINER, SPECIMEN MAILER AND STORAGE, STERILE1

GMDN & GCC registration

  • GMDN code 62970 · non‑implantable
  • Single‑use 99% · sterile 0% · Rx‑only 0% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

No structured size data on the register.

Use these as the dimensions to specify in a tender line.

How many histology tissue cassette ivd, laboratory processing, single-use products are registered in the US?

2,121 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Histology tissue cassette IVD, laboratory processing, single-use", from 12 companies. The largest labeler is Simport Scientific Inc. with 60% of records.

Which FDA product codes apply?

IDZ (Cassettes, Tissue), IDZ (CASSETTES, TISSUE), KET (FILTERS, CELL COLLECTION, TISSUE PROCESSING), KER (Container, Embedding)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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