Identity
- Trade Name
- IHC FDA UDI
- Generic Name
- MSH6 antigen IVD, antibody FDA UDI
- Device Name
- MSH6, Clone 44, 6mL (Manual Use) FDA UDI
- Model / Reference
- (BTO) Manual RTU MSH6 (44) Antibody (6ml) FDA UDI
- Description
- MSH6, Clone 44, 6mL (Manual Use) FDA UDI
Identifiers
- Catalog Number
- MM106-6 FDA UDI
- Primary DI / UDI-DI
- 00810170550386 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- MSH6 antigen 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: MSH6 antigen IVD, antibody
The IHC device is a manual use routine (MUR) test used to detect the MSH6 antibody in clinical specimens, providing a qualitative and/or quantitative detection of this antigen. This test is designed for hematology testing and has been certified by the Food and Drug Administration (FDA).
Similar devices
Also classified as MSH6 antigen IVD, antibody.
- MSH6 — BIOCARE MEDICAL, LLC · Class I
- Tinto MSH6 (RBT-MSH6) — BIO SB, INC. · Class I
- Novocastra — Leica Biosystems Newcastle, Limited · Class I
- MSH6 — BIOCARE MEDICAL, LLC · Class I
- MSH6 IHC pharmDx (Dako Omnis) — Agilent Technologies Inc. · Class III
- Rabbit Monoclonal Anti-Human MSH6 Antibody, EP49 — EPITOMICS, INC. · Class I
- MSH6 — BIOCARE MEDICAL, LLC · Class I
- MSH6 — BIOCARE MEDICAL, 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 0ef62d8c-6491-4819-8009-caec74cc95b1 34 fields · synced Jul 31, 2026