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Richard-Allan Scientific LLC

United States·US-MF-000008261

Last updated September 17, 2026

What Richard-Allan Scientific LLC makes

Richard-Allan Scientific LLC manufactures in vitro diagnostic (IVD) products for histology, cytology, and immunohistochemistry, including enzyme immunohistochemistry kits for estrogen/progesterone receptor detection, reusable microtome blades, biological stains, formalin substitutes, urine specimen collection kits, and single-use tissue cassettes. Their portfolio also covers cytology fixative solutions and reusable microtome blades designed for laboratory processing.

The company’s devices are regulated under FDA’s Class I and Class II classifications and are listed in the FDA’s Unique Device Identifier (UDI) database. Richard-Allan Scientific LLC is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Richard-Allan Scientific LLC manufacture?

Richard-Allan Scientific LLC specializes in in vitro diagnostic (IVD) products primarily used in histology, cytology, and immunohistochemistry. Their portfolio includes enzyme immunohistochemistry kits for detecting estrogen and progesterone receptors, reusable microtome blades for tissue sectioning, biological stains for sample preparation, formalin substitutes to replace traditional formalin, urine specimen collection kits, and single-use tissue cassettes for laboratory processing. These devices support diagnostic testing in pathology and laboratory settings.

Where is Richard-Allan Scientific LLC based?

Richard-Allan Scientific LLC is headquartered in the United States. The company’s location in the US influences its regulatory framework, as its devices are subject to FDA oversight.

Which regulatory registries or databases list Richard-Allan Scientific LLC’s devices?

Richard-Allan Scientific LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the US, ensuring transparency and traceability for healthcare providers and regulators.

How are Richard-Allan Scientific LLC’s devices classified under FDA regulations?

Richard-Allan Scientific LLC’s devices fall under FDA’s Class I and Class II classifications. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and may require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential harm, and the nature of its diagnostic purpose.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: United States
Address: 4481 Campus Drive, Kalamazoo, United States
Website: epredia.com
LinkedIn: —
Facebook: —
Email: #[email protected]
Phone: —
PRRC Contact: Naveen Kaki
EUDAMED SRN: US-MF-000008261
FDA FEI Number: 1831638
DUNS Number: —

Catalogue (1838)

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Device	Model / Reference	Registries	Class	Status
Thermo Scientific	RM-2111-S	FDA UDI	Class I	Active
Thermo Scientific	MS-1898-S	FDA UDI	Class I	Active
Thermo Scientific	MS-1933-P0	FDA UDI	Class I	Active
Thermo Scientific	MS-123-R7	FDA UDI	Class I	Active
Epredia	Microtome Knife, 16 CM, D	FDA UDI	Class I	Active
Thermo Scientific	MS-1074-S0	FDA UDI	Class I	Active
Thermo Scientific	MS-355-R7	FDA UDI	Class I	Active
Thermo Scientific	MS-1898-S0	FDA UDI	Class I	Active
Thermo Scientific	MS-363-R7	FDA UDI	Class I	Active
Thermo Scientific	MS-741-P1	FDA UDI	Class I	Active
Thermo Scientific	MS-393-S0	FDA UDI	Class I	Active
Thermo Scientific	RB-1460-A0	FDA UDI	Class I	Active
Thermo Scientific	MS-1037-RQ	FDA UDI	Class I	Active
Thermo Scientific	MS-1498-S1	FDA UDI	Class I	Active
Thermo Scientific	MS-144-P1	FDA UDI	Class I	Active
Thermo Scientific	RB-9202-P0	FDA UDI	Class I	Active
Thermo Scientific	MS-1169-P	FDA UDI	Class I	Active
Thermo Scientific	MS-321-P	FDA UDI	Class I	Active
Thermo Scientific	RB-360-R7	FDA UDI	Class I	Active
Thermo Scientific	MS-354-P	FDA UDI	Class I	Active
Thermo Scientific	TL-060-QHL	FDA UDI	Class I	Active
Thermo Scientific	RM-2116-R7	FDA UDI	Class I	Active
Epredia	Microtome Knife, 30CM, C	FDA UDI	Class I	Active
Thermo Scientific	RM-2122-S	FDA UDI	Class I	Active
Thermo Scientific	RB-082-R7	FDA UDI	Class I	Active
Thermo Scientific	MS-1826-S0	FDA UDI	Class I	Active
Thermo Scientific	MS-379-P1	FDA UDI	Class I	Active
Thermo Scientific	MS-377-RQ	FDA UDI	Class I	Active
Thermo Scientific	RB-1433-A0	FDA UDI	Class I	Active
Thermo Scientific	MS-186-P0	FDA UDI	Class I	Active
Thermo Scientific	MS-364-RQ	FDA UDI	Class I	Active
Thermo Scientific	RM-9133-R7	FDA UDI	Class I	Active
Thermo Scientific	MS-112-P0	FDA UDI	Class I	Active
Thermo Scientific	RM-9105-R7	FDA UDI	Class I	Active
Epredia	MS-1919-A1-A	FDA UDI	Class I	Active
Thermo Scientific	RB-9291-P	FDA UDI	Class I	Active
Thermo Scientific	MS-1814-RQ	FDA UDI	Class I	Active
Thermo Scientific	MS-743-S	FDA UDI	Class I	Active
Thermo Scientific	RB-1459-A1	FDA UDI	Class I	Active
Thermo Scientific	TA-125-ADQ	EUDAMEDFDA UDI	Class I	Active
Thermo Scientific	RB-1460-A	FDA UDI	Class I	Active
Thermo Scientific	RB-9030-P1	FDA UDI	Class I	Active
Thermo Scientific	MS-1151-S	FDA UDI	Class I	Active
Thermo Scientific	RM-2101-RQ	FDA UDI	Class I	Active
Thermo Scientific	MS-1936-R7	FDA UDI	Class I	Active
Thermo Scientific	MS-1447-S1	FDA UDI	Class I	Active
Progesterone Receptor Ready to use IHC (UVLP)	RM-9102-R7	FDA UDI	Class II	Active
Thermo Scientific	RM-2118-RQ	FDA UDI	Class I	Active
Thermo Scientific	MS-1086-S	FDA UDI	Class I	Active
Thermo Scientific	RM-2102-S0	FDA UDI	Class I	Active

Related Companies

Authorised Representatives

Epredia Netherlands B.V. NL

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (15)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Richard-Allan Scientific LLC has 15 recall records initiated between August 12, 2011, and June 4, 2018, all of which are marked as terminated. The reasons cited include product mislabeling, incorrect dye composition (e.g., Crystal Violet instead of Methylene Blue), potential contamination (e.g., potassium hydroxide or fungal contamination), incorrect product shipment (e.g., Type 6 Paraffin instead of Type 3 Paraffin), and deviations in specified concentrations or lot labeling.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Jun 4, 2018	Z-2749-2018	—	terminated	Mislabeled product
Mar 15, 2017	Z-1895-2017	—	terminated	Methylene Blue, Solution #3 in the Kwik Diff Kit was not Methylene Blue but Crystal Violet instead.
Jun 13, 2016	Z-2351-2016	—	terminated	potential contamination with potassium hydroxide may have an impact when performing immunohistochemistry testing. It is unknown whether the contamination will affect tissue antigenicity. If it were to affect tissue antigenicity, the outcome would be risk of false positive or false negative test results which may lead to serious injury. There is the possibility the patient may need to be re-biopsied.
Feb 16, 2016	Z-1319-2016	—	terminated	Multiple complaints were received from customers indicating that they ordered product 8335(Type 3 Paraffin) but when they opened the box, they found product 8336 (Type 6 Paraffin) inside.
Apr 29, 2015	Z-1639-2015	—	terminated	Richard Allan Scientific (RAS) is initiating a recall of Mucolytic agent and Mucolexx following a customer complaint reporting that a lab had found fungal contamination in 2 lots of Mucolexx.
Apr 29, 2015	Z-1640-2015	—	terminated	Richard Allan Scientific (RAS) is initiating a recall of Mucolytic agent and Mucolexx following a customer complaint reporting that a lab had found fungal contamination in 2 lots of Mucolexx.
Feb 19, 2015	Z-1264-2015	—	terminated	The case was correctly labeled as REF 7501R, however the gallon bottle was incorrectly labeled as REF 7501G Cyto-Stain G. The bottle label has the correct lot number of 313833 and EXP date 11/2016. The gallon bottle contains the correct intended contents of 7501R: Cyto-Stain R Stain.
Sep 17, 2014	Z-0012-2015	—	terminated	The affected lots could have NBF concentrations that are lower or higher than the desired specifications.
Sep 17, 2014	Z-0018-2015	—	terminated	The affected lots could have NBF concentrations that are lower or higher than the desired specifications.
Sep 17, 2014	Z-0017-2015	—	terminated	The affected lots could have NBF concentrations that are lower or higher than the desired specifications.
Sep 17, 2014	Z-0015-2015	—	terminated	The affected lots could have NBF concentrations that are lower or higher than the desired specifications.
Sep 17, 2014	Z-0013-2015	—	terminated	The affected lots could have NBF concentrations that are lower or higher than the desired specifications.
Sep 17, 2014	Z-0014-2015	—	terminated	The affected lots could have NBF concentrations that are lower or higher than the desired specifications.
Sep 17, 2014	Z-0016-2015	—	terminated	The affected lots could have NBF concentrations that are lower or higher than the desired specifications.
Aug 12, 2011	Z-0039-2012	—	terminated	The firm has received two complaints of finger lacerations in operators of this device.