EUDAMED update: May 20, 2026

One Lambda, Inc.

US-MF-000024901

Active35 devices

Address: Roscoe Blvd., 22801 91304 West Hills
Role: Manufacturer
Date of registration: Jun 9, 2022
Country: United States

One Lambda, Inc. is a medical device manufacturer registered in EUDAMED. The company has 35 devices on the EU market across 32 countries. It holds 1 valid CE certificate. Headquartered in West Hills, United States. Explore the regulatory profile, devices and certificates on MD Atlas.

About One Lambda, Inc.

: US-MF-000024901
Role: Manufacturer
Country: United States
Organization name: One Lambda, Inc.
EU VAT number: Not applicable
Date of registration: Jun 9, 2022

Contact details for One Lambda, Inc.

Phone: +(747)-494-1000
Email: sheryl.skinner@thermofisher.com
Website: https://www.thermofisher.com/onelambda/us/en/home.html
Address: 22801, ROSCOE BLVD. 91304 WEST HILLS UNITED STATES

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Competent authority

Name: DE/CA09 - Staatliches Gewerbeaufsichtsamt Hannover

Phone: -
Email: poststelle@gaa-h.niedersachsen.de

Officers and regulatory representatives of One Lambda, Inc.

SKINNER Sheryl
1. The conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released; 2. The technical documentation and the EU declaration of conformity are drawn up and kept up-to-date 3. The post-market surveillance obligations are complied with in accordance with Article 10(9) 4. The reporting obligations referred to in Articles 82 to 86 are fulfilled
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Connected operators

Importers

5 EU importers place this manufacturer's devices

Product	Trade name	Reference / catalog number	Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →	Quantity	Status
C1qScreen Class I Positive Control	C1qScreen Class I Positive Control	`C1QS-PC1`	`00812117017853`	1	On the market
C1qScreen Class II Postive Control	C1qScreen Class II Postive Control	`C1QS-PC2`	`00812117017860`	1	On the market
C1qScreen Negative Control Serum	C1qScreen Negative Control Serum	`C1QS-NC`	`00812117016641`	1	On the market
C1qScreen™	C1qScreen™	`C1Q`	`00812117016658`	1	On the market
LABScreen™ Negative Control	LABScreen™ Negative Control	`LS-NC`	`00812117015224`	1	On the market
LABScreen™ PRA Class I	LABScreen™ PRA Class I	`LS1PRA`	`00812117011561`	1	On the market
LABScreen™ Single Antigen HLA Class II ExPlex - Group 2	LABScreen™ Single Antigen HLA Class II ExPlex - Group 2	`LS2AEX02`	`00814695025961`	1	On the market
LABType™ SSO Typing Test	LABType™ SSO Typing Test	`RSSO1A`	`00812117011042`	1	On the market
LinkSēq HLA-ABC 384 Typing Kit	LinkSēq HLA-ABC 384 Typing Kit	`1822C`	`00814695025411`	1	On the market
LinkSēq HLA-ABC 384 Typing Kit	LinkSēq HLA-ABC 384 Typing Kit	`1821C`	`00814695025398`	1	On the market
LinkSēq HLA-ABCDRDQA1DQB1 384 Typing Kit	LinkSēq HLA-ABCDRDQA1DQB1 384 Typing Kit	`1550C`	`00814695025299`	1	On the market
LinkSēq HLA-ABCDRDQB1 384 Typing Kit	LinkSēq HLA-ABCDRDQB1 384 Typing Kit	`1551C`	`00814695025312`	1	On the market
LinkSēq HLA-ABCDRDQB1 384 Typing Kit	LinkSēq HLA-ABCDRDQB1 384 Typing Kit	`1554C`	`00814695025336`	1	On the market
LinkSēq HLA-ABCDRDQB1 Typing Kit	LinkSēq HLA-ABCDRDQB1 Typing Kit	`1054C-RLC`	`00814695025268`	1	On the market
LinkSēq HLA-ABCDRDQB1 Typing Kit	LinkSēq HLA-ABCDRDQB1 Typing Kit	`1054C-ABS`	`00814695025251`	1	On the market
LinkSēq HLA-ABCDRDQDP SABR 384 Typing Kit	LinkSēq HLA-ABCDRDQDP SABR 384 Typing Kit	`1580C`	`00814695025374`	1	On the market
LinkSēq HLA-ABCDRDQDP+ 384 Typing Kit	LinkSēq HLA-ABCDRDQDP+ 384 Typing Kit	`1575C`	`00814695025350`	1	On the market
LinkSēq HLA-ABDR 384 Typing Kit	LinkSēq HLA-ABDR 384 Typing Kit	`3331C`	`00814695025534`	1	On the market
LinkSēq HLA-ABDR 384 Typing Kit	LinkSēq HLA-ABDR 384 Typing Kit	`3332C`	`00814695025558`	1	On the market
LinkSēq HLA-B 384 Typing Kit	LinkSēq HLA-B 384 Typing Kit	`2321C`	`00814695025497`	1	On the market
LinkSēq HLA-B 384 Typing Kit	LinkSēq HLA-B 384 Typing Kit	`2322C`	`00814695025510`	1	On the market
LinkSēq HLA-B*57:01 Typing Kit	LinkSēq HLA-B*57:01 Typing Kit	`8020C-SR`	`00814695025657`	1	On the market
LinkSēq HLA-B*57:01 Typing Kit	LinkSēq HLA-B*57:01 Typing Kit	`8020C-SL`	`00814695025640`	1	On the market
LinkSēq HLA-B27 Typing Kit	LinkSēq HLA-B27 Typing Kit	`8011C-SL`	`00814695025602`	1	On the market
LinkSēq HLA-B27 Typing Kit	LinkSēq HLA-B27 Typing Kit	`8011C-SR`	`00814695025619`	1	On the market

Product	Trade name	Reference / catalog number	Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →	Quantity	Status
C1qScreen Class I Positive Control	C1qScreen Class I Positive Control	`C1QS-PC1`	`00812117017853`	1	On the market
C1qScreen Class II Postive Control	C1qScreen Class II Postive Control	`C1QS-PC2`	`00812117017860`	1	On the market
C1qScreen Negative Control Serum	C1qScreen Negative Control Serum	`C1QS-NC`	`00812117016641`	1	On the market
C1qScreen™	C1qScreen™	`C1Q`	`00812117016658`	1	On the market
LABScreen™ Negative Control	LABScreen™ Negative Control	`LS-NC`	`00812117015224`	1	On the market
LABScreen™ PRA Class I	LABScreen™ PRA Class I	`LS1PRA`	`00812117011561`	1	On the market
LABScreen™ Single Antigen HLA Class II ExPlex - Group 2	LABScreen™ Single Antigen HLA Class II ExPlex - Group 2	`LS2AEX02`	`00814695025961`	1	On the market
LABType™ SSO Typing Test	LABType™ SSO Typing Test	`RSSO1A`	`00812117011042`	1	On the market
LinkSēq HLA-ABC 384 Typing Kit	LinkSēq HLA-ABC 384 Typing Kit	`1822C`	`00814695025411`	1	On the market
LinkSēq HLA-ABC 384 Typing Kit	LinkSēq HLA-ABC 384 Typing Kit	`1821C`	`00814695025398`	1	On the market
LinkSēq HLA-ABCDRDQA1DQB1 384 Typing Kit	LinkSēq HLA-ABCDRDQA1DQB1 384 Typing Kit	`1550C`	`00814695025299`	1	On the market
LinkSēq HLA-ABCDRDQB1 384 Typing Kit	LinkSēq HLA-ABCDRDQB1 384 Typing Kit	`1551C`	`00814695025312`	1	On the market
LinkSēq HLA-ABCDRDQB1 384 Typing Kit	LinkSēq HLA-ABCDRDQB1 384 Typing Kit	`1554C`	`00814695025336`	1	On the market
LinkSēq HLA-ABCDRDQB1 Typing Kit	LinkSēq HLA-ABCDRDQB1 Typing Kit	`1054C-RLC`	`00814695025268`	1	On the market
LinkSēq HLA-ABCDRDQB1 Typing Kit	LinkSēq HLA-ABCDRDQB1 Typing Kit	`1054C-ABS`	`00814695025251`	1	On the market
LinkSēq HLA-ABCDRDQDP SABR 384 Typing Kit	LinkSēq HLA-ABCDRDQDP SABR 384 Typing Kit	`1580C`	`00814695025374`	1	On the market
LinkSēq HLA-ABCDRDQDP+ 384 Typing Kit	LinkSēq HLA-ABCDRDQDP+ 384 Typing Kit	`1575C`	`00814695025350`	1	On the market
LinkSēq HLA-ABDR 384 Typing Kit	LinkSēq HLA-ABDR 384 Typing Kit	`3331C`	`00814695025534`	1	On the market
LinkSēq HLA-ABDR 384 Typing Kit	LinkSēq HLA-ABDR 384 Typing Kit	`3332C`	`00814695025558`	1	On the market
LinkSēq HLA-B 384 Typing Kit	LinkSēq HLA-B 384 Typing Kit	`2321C`	`00814695025497`	1	On the market
LinkSēq HLA-B 384 Typing Kit	LinkSēq HLA-B 384 Typing Kit	`2322C`	`00814695025510`	1	On the market
LinkSēq HLA-B*57:01 Typing Kit	LinkSēq HLA-B*57:01 Typing Kit	`8020C-SR`	`00814695025657`	1	On the market
LinkSēq HLA-B*57:01 Typing Kit	LinkSēq HLA-B*57:01 Typing Kit	`8020C-SL`	`00814695025640`	1	On the market
LinkSēq HLA-B27 Typing Kit	LinkSēq HLA-B27 Typing Kit	`8011C-SL`	`00814695025602`	1	On the market
LinkSēq HLA-B27 Typing Kit	LinkSēq HLA-B27 Typing Kit	`8011C-SR`	`00814695025619`	1	On the market

One Lambda, Inc.

About One Lambda, Inc.

Contact details for One Lambda, Inc.

Export the 35 devices of One Lambda, Inc.

Competent authority

Officers and regulatory representatives of One Lambda, Inc.

Connected operators

Importers

Related searches

About One Lambda, Inc.

Contact details for One Lambda, Inc.

Export the 35 devices of One Lambda, Inc.

Competent authority

Officers and regulatory representatives of One Lambda, Inc.

Statistics for One Lambda, Inc.

Certificate health for One Lambda, Inc.

Related documents

Devices by risk class

Market presence of One Lambda, Inc.

Device catalog for One Lambda, Inc.

Device families (Basic UDI-DI) of One Lambda, Inc.

Connected operators

Importers

Related searches

Statistics for One Lambda, Inc.

Market presence of One Lambda, Inc.

Devices by risk class

Certificate health for One Lambda, Inc.

Related documents

Device catalog for One Lambda, Inc.

Device families (Basic UDI-DI) of One Lambda, Inc.