Identity
- Trade Name
- IHC FDA UDI
- Generic Name
- Coagulation factor VIII IVD, antibody FDA UDI
- Model / Reference
- (BTO) Sample FactorXIII-A (AC-1A1) Antibody (2ml) FDA UDI
Identifiers
- Catalog Number
- SAM-MM77-2 FDA UDI
- Primary DI / UDI-DI
- 00810170553189 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- Coagulation factor VIII 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: Coagulation factor VIII IVD, antibody
Ihc by Slmp, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Coagulation factor VIII IVD, antibody.
- Factor VIII — BIOCARE MEDICAL, LLC · Class I
- Recombinant Factor VIII Substrate, Porcine Sequence — Takeda Pharmaceuticals U.S.A., Inc. · Class II
- Factor VIII — BIOCARE MEDICAL, LLC · Class I
- Factor VIII — BIOCARE MEDICAL, LLC · Class I
- IHC — Slmp, LLC · Class I
- IHC — Slmp, LLC · Class I
- IHC — Slmp, LLC · Class I
- IHC — Slmp, 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
- Slmp, LLC
Sources (1)
- FDA UDI 0bed6310-5ee9-4749-9253-84b120ca4d9d 33 fields · synced May 30, 2026