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FLEX Mono Mo A-Hu Octamer-Binding Transcription Factor 3/4 Cl N1NK RTU (Link)
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- FLEX Mono Mo A-Hu Octamer-Binding Transcription Factor 3/4 Cl N1NK RTU (Link) FDA UDI
- Generic Name
- Oct-3/4 IVD, antibody FDA UDI
- Device Name
- FLEX Monoclonal Mouse Anti-Human Octamer-Binding Transcription Factor 3/4 Clone N1NK Ready-to-Use (Link) FDA UDI
- Model / Reference
- IR092 FDA UDI
- Description
- FLEX Monoclonal Mouse Anti-Human Octamer-Binding Transcription Factor 3/4 Clone N1NK Ready-to-Use (Link) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05700571107225 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- Oct-3/4 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: Oct-3/4 IVD, antibody
FLEX Mono Mo A-Hu Octamer-Binding Transcription Factor 3/4 Cl N1NK RTU (Link) by Agilent Technologies Inc. — Class I — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Oct-3/4 IVD, antibody.
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- OCT 3/4 [N1NK] — BIOCARE MEDICAL, LLC · Class I
- Mouse Monoclonal Anti-Human OCT3/4(MX084) Antibody — Fuzhou Maixin Biotech Co., Ltd. · Class I
- OCT 3/4 [N1NK] — BIOCARE MEDICAL, LLC · Class I
- Mouse Monoclonal Anti-Human OCT3/4(MX084) Antibody — Fuzhou Maixin Biotech Co., Ltd. · Class I
- OCT 3/4 [N1NK] — BIOCARE MEDICAL, LLC · Class I
- OCT 3/4 [N1NK] — BIOCARE MEDICAL, LLC · Class I
- OCT 3/4 [N1NK] — BIOCARE MEDICAL, LLC · 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
- Agilent Technologies Inc.
Sources (1)
- FDA UDI 3f7d7b11-0914-47f0-b1a7-af1a958824dc 36 fields · synced Jun 8, 2026