Identity
- Trade Name
- IHC FDA UDI
- Generic Name
- Postmeiotic segregation increased 2 (PMS2) IVD, antibody FDA UDI
- Device Name
- PMS2, Clone A16-4/Clone EP51, 6mL (Manual) FDA UDI
- Model / Reference
- (BTO) Manual RTU PMS2 (A16-4) Antibody (6ml) FDA UDI
- Description
- PMS2, Clone A16-4/Clone EP51, 6mL (Manual) FDA UDI
Identifiers
- Catalog Number
- MM127-6 FDA UDI
- Primary DI / UDI-DI
- 00810170550553 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- Postmeiotic segregation increased 2 (PMS2) 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: Postmeiotic segregation increased 2 (PMS2) IVD, antibody
Ihc by Slmp, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Tinto PMS2, MMab — BIO SB, INC. · Class I
- PMS2, MMab — BIO SB, INC. · Class I
- Tinto PMS2 (RBT-PMS2) — BIO SB, INC. · Class I
- BOND™ — Leica Biosystems Newcastle, Limited · Class I
- PMS2 (RBT-PMS2) — BIO SB, 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 |
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Manufacturer
- Manufacturer
- Slmp, LLC
Sources (1)
- FDA UDI 4cc92c65-4c33-48c3-bbca-cd49249f42a0 34 fields · synced May 30, 2026