Identity
- Trade Name
- Mono Mo A-Hu Thyroid Peroxidase Cl MoAb47 FDA UDI
- Generic Name
- Thyroid peroxidase (TPO) IVD, antibody FDA UDI
- Device Name
- Monoclonal Mouse Anti-Human Thyroid Peroxidase Clone MoAb47 FDA UDI
- Model / Reference
- M7257 FDA UDI
- Description
- Monoclonal Mouse Anti-Human Thyroid Peroxidase Clone MoAb47 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05700572027997 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- Thyroid peroxidase (TPO) 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
Dimensions & Sizes
- Size
- Total Volume — 0.2 Milliliter FDA UDI
Category: Thyroid peroxidase (TPO) IVD, antibody
Mono Mo A-Hu Thyroid Peroxidase Cl MoAb47 by Agilent Technologies Singapore Pte Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Thyroid peroxidase (TPO) IVD, antibody.
- Q-STAIN® QSX-Enh-F TPO — NOVODIAX, INC. · Class I
- ihcDirect® TPO Ab Conjugate 15mL — NOVODIAX, INC. · Class I
- ihcDirect® TPO Ab Conjugate 5mL — NOVODIAX, INC. · Class I
- Mouse Monoclonal Anti-Human Thyroid Peroxidase(TPO)(MX113) Antibody — Fuzhou Maixin Biotech Co., Ltd. · Class I
- Q-STAIN® QSX-Enh-P TPO — NOVODIAX, INC. · Class I
- Mouse Monoclonal Anti-Human Thyroid Peroxidase(TPO)(MX113) Antibody — Fuzhou Maixin Biotech Co., Ltd. · Class I
- Novocastra — Leica Biosystems Newcastle, Limited · Class I
- Mouse Monoclonal Anti-Human Thyroid Peroxidase(TPO)(MX113) Antibody — Fuzhou Maixin Biotech Co., Ltd. · 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
- Agilent Technologies Singapore Pte Ltd
Sources (1)
- FDA UDI 91cd1809-009e-4d89-a648-e31f7a6bf8a5 36 fields · synced May 31, 2026