Identity
- Trade Name
- IHC FDA UDI
- Generic Name
- Napsin A IVD, antibody FDA UDI
- Model / Reference
- (BTO) Sample PDM154-2MM FDA UDI
Identifiers
- Catalog Number
- SAM-MM113-2 FDA UDI
- Primary DI / UDI-DI
- 00810170552441 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- Napsin A 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Napsin A IVD, antibody
Ihc by Slmp, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Napsin A IVD, antibody.
- Mouse Monoclonal Anti-Human Napsin A(MX015) Antibody — Fuzhou Maixin Biotech Co., Ltd. · Class I
- Napsin A — BIOCARE MEDICAL, LLC · Class I
- ihcDirect® Napsin A Ab-Enh 15mL — NOVODIAX, INC. · Class I
- Napsin A (RM) — BIOCARE MEDICAL, LLC · Class I
- Napsin A Rabbit Polyclonal Antibody — CELL MARQUE CORPORATION · Class I
- Tissue-Tek Genie® DUO — Sakura Finetek USA, Inc · Class I
- Napsin A Rabbit Polyclonal Antibody — CELL MARQUE CORPORATION · Class I
- Napsin A Rabbit Polyclonal Antibody — CELL MARQUE CORPORATION · 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
- Slmp, LLC
Sources (1)
- FDA UDI 74a685f7-d650-4967-9b16-384509b1ec68 33 fields · synced May 30, 2026