Identity
- Trade Name
- EMA [Mc-5] FDA UDI
- Generic Name
- Epithelial membrane antigen (EMA) IVD, kit, enzyme immunohistochemistry FDA UDI
- Model / Reference
- CM143B FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00847627006424 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- Epithelial membrane antigen (EMA) IVD, kit, enzyme immunohistochemistry 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
Yes
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: Epithelial membrane antigen (EMA) IVD, kit, enzyme immunohistochemistry
EMA [Mc-5] by Biocare Medical, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Epithelial membrane antigen (EMA) IVD, kit, enzyme immunohistochemistry.
- Q-STAIN® QSX-Enh-F EMA — NOVODIAX, INC. · Class I
- ihcDirect® EMA Ab Conjugate 5mL — NOVODIAX, INC. · Class I
- ihcDirect® EMA Ab Conjugate 15mL — NOVODIAX, INC. · Class I
- Q-STAIN® QSX-Enh-P EMA — NOVODIAX, 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
- Biocare Medical, Llc
Sources (1)
- FDA UDI 2e6c55d1-6539-4017-9a62-ddf512c95254 33 fields · synced May 30, 2026