EU Manufacturer
๐บ๐ธ United States
Active
LGC Clinical Diagnostics, Inc.
SRN: US-MF-000016356
ยท
37 Birch Street , 01757 Milford , United States
Basic UDI-DIs
84
Total Devices
84
On Market
84
Off Market
0
Certificates
10
Valid
0
Expiring < 6mo
0
Countries
30
Basic Information
- Address
- 37 Birch Street , 01757 Milford , United States
- [email protected]
- Phone
- +1 508 244 6400
Regulatory Overview
Regulation
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Eu Ivdd
83
Eu Ivdr
1
Classification
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Eu Ivd General
65
Eu Ivd Annex 2 List B
18
Eu Ivd Class B
1
Device Types
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Certificate Health
Total
10
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
10
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | CE 572691 | BSI Group The Netherlands B.V. | May 12, 2024 | |||
| IVDD Annex IV (excluding sections 4, 6) | CE 572693 | BSI Group The Netherlands B.V. | May 26, 2024 | |||
| IVDD Annex IV (excluding sections 4, 6) | 575325 | BSI Group The Netherlands B.V. | May 26, 2025 | |||
| IVDD Annex IV (excluding sections 4, 6) | CE 575325 | BSI Group The Netherlands B.V. | May 26, 2025 | |||
| IVDD Annex IV (excluding sections 4, 6) | CE 572685 | BSI Group The Netherlands B.V. | May 26, 2025 | |||
| IVDD Annex IV (excluding sections 4, 6) | CE 572694 | BSI Group The Netherlands B.V. | May 26, 2025 | |||
| IVDD Annex IV (excluding sections 4, 6) | CE 572689 | BSI Group The Netherlands B.V. | May 26, 2025 | |||
| IVDD Annex IV (excluding sections 4, 6) | CE 572688 | BSI Group The Netherlands B.V. | May 26, 2025 | |||
| IVDD Annex IV (excluding sections 4, 6) | CE 572687 | BSI Group The Netherlands B.V. | May 26, 2025 | |||
| IVDD Annex IV (excluding sections 4, 6) | CE 572692 | BSI Group The Netherlands B.V. | May 26, 2025 |
Market Presence
Devices from this manufacturer are available in 30 countries across Europe.
๐ฆ๐น Austria
๐ง๐ช Belgium
๐ง๐ฌ Bulgaria
๐จ๐พ Cyprus
๐จ๐ฟ Czechia
๐ฉ๐ช Germany
๐ฉ๐ฐ Denmark
๐ช๐ช Estonia
๐ฌ๐ท Greece
๐ช๐ธ Spain
๐ซ๐ฎ Finland
๐ซ๐ท France
๐ญ๐ท Croatia
๐ญ๐บ Hungary
๐ฎ๐ช Ireland
๐ฎ๐ธ Iceland
๐ฎ๐น Italy
๐ฑ๐ฎ Liechtenstein
๐ฑ๐น Lithuania
๐ฑ๐บ Luxembourg
๐ฑ๐ป Latvia
๐ฒ๐น Malta
๐ณ๐ฑ Netherlands
๐ณ๐ด Norway
๐ต๐ฑ Poland
๐ต๐น Portugal
๐ท๐ด Romania
๐ธ๐ช Sweden
๐ธ๐ฎ Slovenia
๐ธ๐ฐ Slovakia
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| A1 Negative Control | EU IVDD | Eu Ivd General | On Market | 1 |
| A1 Negative Control | EU IVDD | Eu Ivd General | On Market | 1 |
| A1 Series 4400 | EU IVDD | Eu Ivd General | On Market | 1 |
| A1 Series 5600 | EU IVDD | Eu Ivd General | On Market | 1 |
| A106 HIV-1 Ag | EU IVDD | Eu Ivd General | On Market | 1 |
| A106 HIV-1 Ag | EU IVDD | Eu Ivd General | On Market | 1 |
| A113 Anti-HBc IgM | EU IVDD | Eu Ivd General | On Market | 1 |
| A115 Anti-HBc IgG | EU IVDD | Eu Ivd General | On Market | 1 |
| A21 Series 1000 CE | EU IVDD | Eu Ivd General | On Market | 1 |
| A21 Series 2000 CE | EU IVDD | Eu Ivd General | On Market | 1 |
| A325 Series 200 HBV DNA | EU IVDD | Eu Ivd General | On Market | 1 |
| A52 Hepatitis Multi-Marker | EU IVDD | Eu Ivd General | On Market | 1 |
| A810 Negative Control | EU IVDD | Eu Ivd General | On Market | 1 |
| ACCURUN 119 Anti-Hepatitis B e Antigen (Anti-HBe) Positive Control | EU IVDD | Eu Ivd General | On Market | 1 |
| ACCURUN 125 Anti-HBs Positive Control | EU IVDD | Eu Ivd General | On Market | 1 |
| ACCURUN 125 Anti-HBs Positive Control | EU IVDD | Eu Ivd General | On Market | 1 |
| ACCURUN 305 Series 100 HCV RNA | EU IVDD | Eu Ivd General | On Market | 1 |
| ACCURUN 305 Series 150 HCV RNA Positive Control | EU IVDD | Eu Ivd General | On Market | 1 |
| ACCURUN 315 Series 150 HIV-1 RNA | EU IVDD | Eu Ivd General | On Market | 1 |
| ACCURUN 315 Series 400 HIV-1 RNA | EU IVDD | Eu Ivd General | On Market | 1 |
| ACCURUN 345 HIV-1 RNA, HCV RNA, HBV DNA Positive Quality Control Series 150 | EU IVDD | Eu Ivd General | On Market | 1 |
| ACCURUN 345 HIV-1 RNA, HCV RNA, HBV DNA Positive Quality Control Series 150 | EU IVDD | Eu Ivd General | On Market | 1 |
| ACCURUN 51 Multi-Marker Hepatitis Positive Control 1 Series 3000 | EU IVDD | Eu Ivd General | On Market | 1 |
| ACCURUN117 Hepatitis B e Antigen Positive Control | EU IVDD | Eu Ivd General | On Market | 1 |
| A1 Series 2400 | EU IVDD | Eu Ivd General | On Market | 1 |
| A1 Series 2500 | EU IVDD | Eu Ivd General | On Market | 1 |
| A1 Series 2700 | EU IVDD | Eu Ivd General | On Market | 1 |
| A1 Series 4000 | EU IVDD | Eu Ivd General | On Market | 1 |
| A127 Anti-Delta | EU IVDD | Eu Ivd General | On Market | 1 |
| A325 Series 700 HBV DNA | EU IVDD | Eu Ivd General | On Market | 1 |
| A51 Hepatitis Multi-Marker | EU IVDD | Eu Ivd General | On Market | 1 |
| A51 Hepatitis Multi-Marker | EU IVDD | Eu Ivd General | On Market | 1 |
| ACCURUN 120 Anti-HAV IgG | EU IVDD | Eu Ivd General | On Market | 0 |
| ACCURUN 121 HAV IgM Positive Control | EU IVDD | Eu Ivd General | On Market | 0 |
| ACCURUN 121 HAV IgM Positive Control | EU IVDD | Eu Ivd General | On Market | 0 |
| ACCURUN 130 Borrelia burgdorferi IgG Positive Control | EU IVDD | Eu Ivd General | On Market | 0 |
| ACCURUN 132 Borrelia burgdorferi IgM Positive Control | EU IVDD | Eu Ivd General | On Market | 0 |
| ACCURUN 135 Toxoplasma IgG Positive Control | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| ACCURUN 136 Toxoplasma IgM Positive Control | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| ACCURUN 140 Rubella IgG Positive Control | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| ACCURUN 141 Rubella IgM Positive Control | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| ACCURUN 145 CMV IgG Positive Control | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| ACCURUN 146 CMV IgM Positive Control | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| ACCURUN 155 Anti-Treponema (Syphilis) Positive Control Series 2000 | EU IVDD | Eu Ivd General | On Market | 0 |
| ACCURUN 155 Anti-Treponema (Syphilis) Positive Control Series 5000 | EU IVDD | Eu Ivd General | On Market | 0 |
| ACCURUN 155 Anti-Treponema (Syphilis) Positive Control Series 5000 | EU IVDD | Eu Ivd General | On Market | 0 |
| ACCURUN 156 Reagin (Syphilis) Positive Control | EU IVDD | Eu Ivd General | On Market | 0 |
| ACCURUN 190 Chagas Positive Control | EU IVDD | Eu Ivd General | On Market | 0 |
| ACCURUN 25 ToRCH IgG Positive Control S2000 | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| ACCURUN 25 ToRCH IgG Positive Control S5000 | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |