Identity
- Trade Name
- MLB 2 FDA UDI
- Generic Name
- Low ionic-strength salt solution (LISS) immunohaematology reagent IVD FDA UDI
- Device Name
- Modified LISS-Enhancement media for TANGO instruments and tube test; 50 ml FDA UDI
- Model / Reference
- 805200100 FDA UDI
- Description
- Modified LISS-Enhancement media for TANGO instruments and tube test; 50 ml FDA UDI
Identifiers
- Catalog Number
- 805200100 FDA UDI
- Primary DI / UDI-DI
- 07611969965731 FDA UDI
- FDA Product Code
- KSZ FDA UDI
- GMDN Term
- Low ionic-strength salt solution (LISS) immunohaematology reagent IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.9175 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Low ionic-strength salt solution (LISS) immunohaematology reagent IVD
Mlb 2 by Bio-Rad Medical Diagnostics GmbH — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Low ionic-strength salt solution (LISS) immunohaematology reagent IVD.
- ALBAhance LISS Additive Reagent — ALBA BIOSCIENCE LIMITED · Class II
- Gamma N-HANCE — IMMUCOR, INC. · Class II
- LISS — DIAGAST · Class II
- Capture LISS — IMMUCOR, INC. · Class I
- ORTHO — Ortho-Clinical Diagnostics · Class II
- LISS — AMERICAN NATIONAL RED CROSS · Class II
- Gamma N-HANCE — IMMUCOR, INC. · Class II
- Capture LISS — IMMUCOR, INC. · Class I
Cleared under the same submission
BK040070 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Bio-Rad Medical Diagnostics GmbH
Sources (2)
- FDA UDI 6b5befb5-7fa1-4513-8859-022a9d201426 37 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 2, 2026