FDA UDI
In Commercial Distribution
🇺🇸 United States
MTS
DI: 10758750005970
·
Model: MTS081221
·
MICRO TYPING SYSTEMS, INC
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MTS
- Primary DI
- 10758750005970
- Version / Model
- MTS081221
- Catalog Number
- MTS081221
- Company Name
- MICRO TYPING SYSTEMS, INC
- Labeler DUNS
- 781421888
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-10-22
- Public Version
- 7
- Public Version Date
- 2023-03-13
- Public Version Status
- Update
- Public Device Record Key
- 5f527296-05de-4350-bedc-e296837ee032
Device Description
MTS Anti-D (Monoclonal) (IgM) Card
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 52647 | Anti-Rh(D) red blood cell grouping IVD, antibody | One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used in testing a clinical specimen for Rh(D) [RH001] red blood cell antigens from the rhesus system, using an agglutination method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10758750005970 | GS1 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store and ship upright
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 25 Degrees Celsius