Identity
- Trade Name
- Lysozyme ELISA FDA UDI
- Generic Name
- Lysozyme (muramidase) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Model / Reference
- K 6902 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04050598000452 FDA UDI
- FDA Product Code
- JMQ FDA UDI
- GMDN Term
- Lysozyme (muramidase) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1490 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Lysozyme (muramidase) IVD, kit, enzyme immunoassay (EIA)
Lysozyme ELISA by Immundiagnostik, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Lysozyme (muramidase) IVD, kit, enzyme immunoassay (EIA).
- Dengue Virus NS1 Ag ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · Class I
- Lysozym ELISA — IMMUNDIAGNOSTIK, INC. · Class I
- Lysozyme ELISA — IMMUNDIAGNOSTIK, INC. · Class I
- Lysozyme ELISA — IMMUNDIAGNOSTIK, INC. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Immundiagnostik, Inc.
Sources (1)
- FDA UDI 13190bbc-4ead-43c7-91b7-b931daedef71 32 fields · synced May 31, 2026