Identity
- Trade Name
- MTS FDA UDI
- Generic Name
- Anti-Rh(D) red blood cell grouping IVD, antibody FDA UDI
- Device Name
- MTS Anti-D (Monoclonal) (IgM) Card FDA UDI
- Model / Reference
- MTS081221 FDA UDI
- Description
- MTS Anti-D (Monoclonal) (IgM) Card FDA UDI
Identifiers
- Catalog Number
- MTS081221 FDA UDI
- Primary DI / UDI-DI
- 10758750005970 FDA UDI
- GMDN Term
- Anti-Rh(D) red blood cell grouping IVD, antibody FDA UDI
Classification
- 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Anti-Rh(D) red blood cell grouping IVD, antibody
Mts by Micro Typing Systems, Inc — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Anti-Rh(D) red blood cell grouping IVD, antibody.
- Beckman Coulter® PK® Systems Anti-D (PK1) (P3X61) — DIAGAST
- Anti-D (Monoclonal Blend) Series 5 — IMMUCOR, INC.
- ORTHO — Ortho-Clinical Diagnostics
- Anti-D (RH1) IgM+IgG — DIAGAST
- Anti-D (RH1) IgM — DIAGAST
- Anti-D (Monoclonal Blend) Gamma-clone — IMMUCOR, INC.
- IH-Anti D (RH1) Blend — Bio-Rad Medical Diagnostics GmbH
- IH-Card Anti-D (DVI-) — Bio-Rad Medical Diagnostics GmbH
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 | N/A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Micro Typing Systems, Inc
Sources (1)
- FDA UDI 5f527296-05de-4350-bedc-e296837ee032 35 fields · synced May 30, 2026