Identity
- Trade Name
- Tryptase (G3) Mouse Monoclonal Antibody FDA UDI
- Generic Name
- Tryptase IVD, antibody FDA UDI
- Model / Reference
- 342M-15 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841683137245 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- Tryptase IVD, antibody FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.1860 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: Tryptase IVD, antibody
Tryptase (G3) Mouse Monoclonal Antibody by Cell Marque Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tryptase IVD, antibody.
- Rabbit Monoclonal Anti-Human Tryptase Antibody, EP259 — EPITOMICS, INC. · Class I
- Rabbit Monoclonal Anti-Human Tryptase Antibody, EP259 — EPITOMICS, INC. · Class I
- Rabbit Monoclonal Anti-Human Tryptase Antibody, EP259 — EPITOMICS, INC. · Class I
- Tissue-Tek Genie® — Sakura Finetek USA, Inc · Class I
- Rabbit Monoclonal Anti-Human Tryptase Antibody, EP259 — EPITOMICS, INC. · Class I
- Tissue-Tek Genie® — Sakura Finetek USA, Inc · Class I
- Tryptase (G3) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
- Tryptase (G3) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · 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 |
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Manufacturer
- Manufacturer
- Cell Marque Corporation
Sources (1)
- FDA UDI f2f3e41b-bf7c-4fa8-8c8d-4b8f7cab8fdc 33 fields · synced Jun 7, 2026