← Back to catalogue
Mouse Monoclonal Anti-Human Thyroid Peroxidase(TPO)(MX113) Antibody
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Mouse Monoclonal Anti-Human Thyroid Peroxidase(TPO)(MX113) Antibody FDA UDI
- Generic Name
- Thyroid peroxidase (TPO) IVD, antibody FDA UDI
- Model / Reference
- MAB-1018 90mL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06931988330886 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
Yes
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: Thyroid peroxidase (TPO) IVD, antibody
Mouse Monoclonal Anti-Human Thyroid Peroxidase(TPO)(MX113) Antibody by Fuzhou Maixin Biotech Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Thyroid peroxidase (TPO) IVD, antibody.
- Q-STAIN® QSX-Enh-F TPO — NOVODIAX, INC. · Class I
- Mono Mo A-Hu Thyroid Peroxidase Cl MoAb47 — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
- ihcDirect® TPO Ab Conjugate 15mL — NOVODIAX, INC. · Class I
- ihcDirect® TPO Ab Conjugate 5mL — NOVODIAX, INC. · Class I
- Q-STAIN® QSX-Enh-P TPO — NOVODIAX, INC. · 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
- 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
- Fuzhou Maixin Biotech Co., Ltd.
Sources (1)
- FDA UDI ef4b0cc1-23e0-43e8-b1f4-4414bcc455a3 32 fields · synced May 31, 2026