FDA UDI
In Commercial Distribution
🇺🇸 United States
MP Diagnostics HTLV Blot 2.4
DI: 08887581000016
·
Model: 36 test
·
MP BIOMEDICALS ASIA PACIFIC PTE. LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MP Diagnostics HTLV Blot 2.4
- Primary DI
- 08887581000016
- Version / Model
- 36 test
- Catalog Number
- 07110888036
- Company Name
- MP BIOMEDICALS ASIA PACIFIC PTE. LTD.
- Labeler DUNS
- 595128042
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-03-11
- Public Version
- 3
- Public Version Date
- 2021-02-24
- Public Version Status
- Update
- Public Device Record Key
- cdbd4c55-b1f5-46d5-8f5e-6f08a946da35
- Distribution End Date
- 2035-10-02
Device Description
The MP Diagnostics HTLV Blot 2.4 is a qualitative enzyme immunoassay intended for confirming the presence of and differentiating antibodies to HTLV-I and HTLV-II in human serum and plasma. It is intended for use as a supplemental (additional, more specific) test for human serum and plasma samples with repeatedly reactive results by an FDA licensed HTLV-I/II donor screening test. The MP Diagnostics HTLV Blot 2.4 is intended for use in a manual mode or a semi-automated mode using the MP Diagnostics AutoBlot System 20. This test is not intended for use in medical diagnosis.
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
- MR Safe
- 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
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MTP | Antibody To Htlv-1, Elisa | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48525 | Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, kit, immunoblot | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to human T-cell lymphotrophic virus 1 and/or 2 (HTLV1 and/or HTLV2) in a clinical specimen, using an immunoblot assay method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08887581000016 | GS1 |
Customer Contacts
- Phone
- 440.337.1200
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius