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Perkinelmer, Inc.

Last updated May 31, 2026

What Perkinelmer, Inc. makes

Perkinelmer, Inc. manufactures flat panel x-ray detector integration units, including digital x-ray detector systems designed for medical imaging. These systems are used in radiographic applications to capture high-resolution images for diagnostic purposes. The company also produces non-derivatized and derivatized mass spectrometry (MSMS) kits for neonatal screening, as well as sample collection devices for laboratory use.

The company’s products are primarily classified as Class II medical devices under regulatory frameworks. These devices are listed in the FDA’s 510(k) and UDI registries, adhering to U.S. regulatory requirements. The manufacturer operates from 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 Perkinelmer, Inc. primarily manufacture?

Perkinelmer, Inc. specializes in flat panel x-ray detector integration units, particularly digital x-ray detector systems like the XRpad series. These devices are designed for radiographic imaging to produce high-resolution diagnostic images. Additionally, the company produces mass spectrometry (MSMS) kits—both non-derivatized and derivatized—for neonatal screening (e.g., GSP NeonatalGALT Kit) and sample collection devices for laboratory use. Their focus is on imaging technology and diagnostic testing tools.

Where is Perkinelmer, Inc. based, and how does that affect its regulatory compliance?

Perkinelmer, Inc. is headquartered in the United States, which means its devices must comply with U.S. regulatory requirements, including those set by the FDA. Since the company’s products are listed in the FDA’s 510(k) and UDI registries, they undergo premarket review processes (like 510(k) submissions) to demonstrate safety and effectiveness before commercialization. The UDI system also ensures traceability and identification of devices in the market.

How are Perkinelmer’s medical devices classified under U.S. regulations, and why does this matter?

Perkinelmer’s devices are classified as Class II medical devices under U.S. regulations. This classification indicates they pose moderate risk and require special controls (beyond general controls) to ensure safety and performance. Class II devices typically require premarket notifications (510(k)) to demonstrate substantial equivalence to a predicate device or compliance with performance standards. This classification ensures rigorous oversight while balancing innovation with patient safety.

Which regulatory registries list Perkinelmer’s devices, and what information do they provide?

Perkinelmer’s devices are listed in the FDA’s 510(k) and UDI (Unique Device Identification) registries. The 510(k) database shows premarket submissions for devices like their XRpad systems, demonstrating how they meet regulatory requirements for safety and effectiveness. The UDI system assigns unique identifiers to devices (e.g., XRpad 4343 F MED Flat Panel Detector) to improve tracking, reduce medical errors, and enhance transparency in the supply chain. Both registries help healthcare providers and regulators verify device compliance.

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

Information

Country: US
Address: —
Website: perkinelmer.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +496123971300
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 623897670

Catalogue (18)

Device	Model / Reference	Registries	Class	Status
XRpad Digital X-Ray Detector System	XRpad2 3025 HWC-M	FDA UDI	Class II	Active
XRpad Digital X-Ray Detector System	XRpad2 4336 HWC-M	FDA UDI	Class II	Active
XRpad Digital X-Ray Detector System	XRpad 4336 MED	FDA UDI	Class II	Active
XRpad Digital X-Ray Detector System	XRpad 4343 F MED	FDA UDI	Class II	Active
XRpad Digital X-Ray Detector System	XRpad LBC	FDA UDI	Class II	Active
NeoBase 2 Non-derivatized MSMS Kit	K193103	FDA 510(k)	Class II	Active
PerkinElmer, XRpad 4343 F MED Flat Panel Detector	K142698	FDA 510(k)	Class II	Active
Gsp Neonatalgalt Kit, Model 3303-001u	K100101	FDA 510(k)	Class II	Active
NeoLSD MSMS Kit	K190266	FDA 510(k)	Class II	Active
PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector	K161966	FDA 510(k)	Class II	Active
Perkinelmer, Xrpad 4336 Med Flat Panel Detector	K140551	FDA 510(k)	Class II	Active
Perkinelmer 226 Sample Collection Devices	K121864	FDA 510(k)	Class II	Active
Gsp Instrument And Gsp Neonatal Htsh Kit	K090846	FDA 510(k)	Class II	Active
Neobase Non-Derivatized Msms Kit, Model 3040	K083130	FDA 510(k)	Class II	Active
PerkinElmer, XRpad2 3025 HWC-M Flat Panel Detector	K161942	FDA 510(k)	Class II	Active
Neobase Non-Derivatized Msms Kit Model 3040-001u	K093916	FDA 510(k)	Class II	Active
Neonatal Biotinidase Kit, Model 3018	K090123	FDA 510(k)	Class II	Active
Perkinelmer Xrd 1622 Ap3 Med Flat Panel Detector	K122495	FDA 510(k)	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

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Notified Bodies

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Authorities

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FDA Recalls (24)

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

PerkinElmer, Inc. has 24 recall records initiated between January 15, 2009, and October 13, 2016, all of which are recorded as terminated. The reasons cited include barcode identification errors affecting measurement protocols, defective pipette tips leading to inaccurate volume dispensing, potential result code discrepancies due to manual editing, defective microplate wells causing erroneous assay readings, incorrect barcode content in labeling, improperly molded filter tips causing seal failures, and contamination from a GSP Shaker unit impacting assay signal activity.

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
Oct 13, 2016	Z-0780-2017	—	terminated	Defective tips have the potential to pipette/dispense volumes 50-100% lower than is specified for the tips.
Jun 24, 2016	Z-0747-2017	—	terminated	Filter Tips molded incorrectly and may not seal to the Varispan tip adaptor properly causing inaccurate aspiration and dispensing
Dec 8, 2015	Z-0636-2016	—	terminated	The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The second barcode ID label #023 symbol incorrectly identifies as #024 when scanned. If measurement protocols have been programmed for both ID #023 and #024, the protocol associated with barcode ID #024 is executed. If the error is undetected, the Gamma Counter may produce erroneous results.
Dec 8, 2015	Z-0638-2016	—	terminated	The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The second barcode ID label #023 symbol incorrectly identifies as #024 when scanned. If measurement protocols have been programmed for both ID #023 and #024, the protocol associated with barcode ID #024 is executed. If the error is undetected, the Gamma Counter may produce erroneous results.
Dec 8, 2015	Z-0635-2016	—	terminated	The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The second barcode ID label #023 symbol incorrectly identifies as #024 when scanned. If measurement protocols have been programmed for both ID #023 and #024, the protocol associated with barcode ID #024 is executed. If the error is undetected, the Gamma Counter may produce erroneous results.
Dec 8, 2015	Z-0634-2016	—	terminated	The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The second barcode ID label #023 symbol incorrectly identifies as #024 when scanned. If measurement protocols have been programmed for both ID #023 and #024, the protocol associated with barcode ID #024 is executed. If the error is undetected, the Gamma Counter may produce erroneous results.
Dec 8, 2015	Z-0637-2016	—	terminated	The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The second barcode ID label #023 symbol incorrectly identifies as #024 when scanned. If measurement protocols have been programmed for both ID #023 and #024, the protocol associated with barcode ID #024 is executed. If the error is undetected, the Gamma Counter may produce erroneous results.
Dec 8, 2015	Z-0633-2016	—	terminated	The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The second barcode ID label #023 symbol incorrectly identifies as #024 when scanned. If measurement protocols have been programmed for both ID #023 and #024, the protocol associated with barcode ID #024 is executed. If the error is undetected, the Gamma Counter may produce erroneous results.
Dec 8, 2015	Z-0632-2016	—	terminated	The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The second barcode ID label #023 symbol incorrectly identifies as #024 when scanned. If measurement protocols have been programmed for both ID #023 and #024, the protocol associated with barcode ID #024 is executed. If the error is undetected, the Gamma Counter may produce erroneous results.
Jun 3, 2015	Z-2127-2015	—	terminated	Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results
Jun 3, 2015	Z-2125-2015	—	terminated	Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results
Jun 3, 2015	Z-2129-2015	—	terminated	Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results
Jun 3, 2015	Z-2124-2015	—	terminated	Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results
Jun 3, 2015	Z-2126-2015	—	terminated	Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results
Jun 3, 2015	Z-2128-2015	—	terminated	Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results
Jun 3, 2015	Z-2130-2015	—	terminated	Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results
Nov 26, 2012	Z-0690-2013	—	terminated	Truncated V-Bottomed Microplate Wells used in assays contain defective wells.
Nov 26, 2012	Z-0687-2013	—	terminated	Truncated V-Bottomed Microplate Wells used in assays contain defective wells.
Nov 26, 2012	Z-0688-2013	—	terminated	Truncated V-Bottomed Microplate Wells used in assays contain defective wells.
Nov 26, 2012	Z-0689-2013	—	terminated	Truncated V-Bottomed Microplate Wells used in assays contain defective wells.
Nov 26, 2012	Z-0686-2013	—	terminated	Truncated V-Bottomed Microplate Wells used in assays contain defective wells.
Jun 27, 2012	Z-2121-2012	—	terminated	Contamination from GSP Shaker unit results in decreased signal activity of assay measurements for Genetic Screening for Neonatal IRT, TSH and IRT
Jan 15, 2009	Z-1906-2009	—	terminated	If Result Codes are used and if they are manually edited, they are correct unless the laboratory specifically uses the View Assay button in the Specimen History screen to open another assay, and then returns back to the original assay
Jan 15, 2009	Z-1905-2009	—	terminated	If Result Codes are used and if they are manually edited, they are correct unless the laboratory specifically uses the View Assay button in the Specimen History screen to open another assay, and then returns back to the original assay