Identity
- Trade Name
- CD19-PE-Cyanine7 FDA UDI
- Generic Name
- CD19 cell marker IVD, antibody FDA UDI
- Device Name
- CD19-PE-Cyanine7 FDA UDI
- Model / Reference
- CYT-19C4-A FDA UDI
- Description
- CD19-PE-Cyanine7 FDA UDI
Identifiers
- Catalog Number
- CYT-19C4-A FDA UDI
- Primary DI / UDI-DI
- 08436548983406 FDA UDI
- FDA Product Code
- MVU FDA UDI
- GMDN Term
- CD19 cell marker IVD, antibody FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.4020 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
Yes
FDA UDI
Category: CD19 cell marker IVD, antibody
CD19-PE-Cyanine7 by Cytognos Sl — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as CD19 cell marker IVD, antibody.
- CD19 (RM) [RM332] — BIOCARE MEDICAL, LLC · Class I
- Human CD19 Alexa Fluor® 700 Conj. — LIFE TECHNOLOGIES LIMITED · Class I
- BOND™ — Leica Biosystems Newcastle, Limited · Class I
- Mono Mo a Hu CD19/APC Cl HD37 — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
- Mouse Monoclonal Anti-Human CD19(MX016) Antibody — Fuzhou Maixin Biotech Co., Ltd. · Class I
- CD19 (MRQ-36) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
- Human CD19 FITC Conjugate — LIFE TECHNOLOGIES LIMITED · Class I
- Tinto CD19, RMab — BIO SB, 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
- Cytognos Sl
Sources (1)
- FDA UDI ab938d03-6e6f-41cf-af56-ff612b29b985 35 fields · synced May 30, 2026