FDA.reportPublic FDA data

MP Diagnostics HTLV Blot 2.4

Primary DI
00888758100009
Brand
MP Diagnostics HTLV Blot 2.4
Company
MP BIOMEDICALS ASIA PACIFIC PTE. LTD.
Model
18 test
Catalog number
0711088018
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.
Published
2015-03-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MTPAntibody To Htlv-1, Elisa

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MTPAntibody To Htlv-1, ElisaUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888758100009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888758100009008887581000098887581000090888758100009

GMDN Terms#

Term, Definition table
TermDefinition
Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, kit, immunoblotA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
440.337.1200mpHTLV@mpbio.com

Regulatory Flags#

DUNS number
595128042
Device count
1
DM exempt
false
Premarket exempt
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08887581000009MP Diagnostics HTLV Blot 2.4 18 test07110880182015-03-11
08887581000016MP Diagnostics HTLV Blot 2.436 test071108880362015-03-11
00888758100016MP Diagnostics HTLV Blot 2.436 test071108880362015-03-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08887581000009MP Diagnostics HTLV Blot 2.4 MP BIOMEDICALS ASIA PACIFIC PTE. LTD.MTP2015-03-11
08887581000016MP Diagnostics HTLV Blot 2.4MP BIOMEDICALS ASIA PACIFIC PTE. LTD.MTP2015-03-11
00888758100016MP Diagnostics HTLV Blot 2.4MP BIOMEDICALS ASIA PACIFIC PTE. LTD.MTP2015-03-11