FDA.reportPublic FDA data

MP Diagnostics HTLV Blot 2.4

Primary DI
08887581000016
Brand
MP Diagnostics HTLV Blot 2.4
Company
MP BIOMEDICALS ASIA PACIFIC PTE. LTD.
Model
36 test
Catalog number
07110888036
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 Safe
Rx
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
08887581000016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08887581000016088875810000168887581000016

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

Contacts#

Phone, Email table
PhoneEmail
440.337.1200mpHTLV@mpbio.com

Regulatory Flags#

DUNS number
595128042
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08887581000009MP Diagnostics HTLV Blot 2.4 18 test07110880182015-03-11
00888758100009MP Diagnostics HTLV Blot 2.4 18 test07110880182015-03-11
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
00888758100009MP Diagnostics HTLV Blot 2.4 MP BIOMEDICALS ASIA PACIFIC PTE. LTD.MTP2015-03-11
00888758100016MP Diagnostics HTLV Blot 2.4MP BIOMEDICALS ASIA PACIFIC PTE. LTD.MTP2015-03-11