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Sign in to claim this brandMEDICAL & BIOLOGICAL LABORATORIES CO., LTD.
Japan·JP-MF-000017864
Last updated May 30, 2026
What MEDICAL & BIOLOGICAL LABORATORIES CO., LTD. makes
Medical & Biological Laboratories Co., Ltd. manufactures in vitro diagnostic (IVD) enzyme immunoassay (EIA) kits for detecting autoantibodies linked to autoimmune blistering diseases. Their products include kits for identifying BPAG1 and BPAG2 antibodies (e.g., MESACUP BP180 and BP230 ELISA Kits), as well as DSG1 and DSG3 antibodies (e.g., DSG-1 & DSG-3 ELISA Test System). Additional offerings cover anti-integrin αvβ6 antibodies and Factor XIII assays, such as HEXAMATE Factor XIII calibrators and controls.
The company’s diagnostic kits are classified as Class B (in vitro diagnostic medical devices) and Class II (in vitro diagnostic reagents) under regulatory frameworks. Their products are listed in the EU’s eudamed registry and the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in Japan.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- Japan
- Address
- 1063-103 Terasawaoka, Ina-shi, Nagano-ken, Japan
- Website
- mbl.co.jp
- —
- —
- [email protected]
- Phone
- 8475445044
- PRRC Contact
- Uichiro Yabe
- EUDAMED SRN
- JP-MF-000017864
- FDA FEI Number
- —
- DUNS Number
- 691688915
Catalogue (12)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| MESACUP BP180 ELISA Kit | 48 wells | FDA UDI | Class II | Active |
| DSG-1 & DSG-3 ELISA Test System | DSG1 48 wells and DSG3 48 wells. | FDA UDI | Class II | Unknown |
| MESACUP BP230 ELISA Kit | 48 wells | FDA UDI | Class II | Active |
| DSG-1 & DSG-3 ELISA Test System | DSG1 48 wells and DSG3 48 wells. | FDA UDI | Class II | Active |
| Anti-Integrin αvβ6 ELISA Kit (IVD) | 7670E | EUDAMED | Class B | Active |
| MESACUP-2 TEST Desmoglein 1 | 7881E | EUDAMED | Class B | Active |
| MESACUP-2 TEST Desmoglein 3 | 7886E | EUDAMED | Class B | Active |
| HEXAMATE Factor XIII - Calibrator | 04942362R | EUDAMED | Class B | Active |
| Mesacup Bp180 Test | 7697E | EUDAMED | Class B | Active |
| HEXAMATE Factor XIII-Control I/II | 04942371R | EUDAMED | Class B | Active |
| Mesacup Bp230 Test | 7614E | EUDAMED | Class B | Active |
| MESACUP TypeVII Collagen TEST | 7846E | EUDAMED | Class B | Active |
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- QbD RepS BV BE
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