AccessGUDID - DEVICE: MP Diagnostics HTLV Blot 2.4 (08887581000016)

GUDID

Device Identifier (DI) Information

Brand Name: MP Diagnostics HTLV Blot 2.4
Version or Model: 36 test
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 07110888036
Company Name: MP BIOMEDICALS ASIA PACIFIC PTE. LTD.

Primary DI Number: 08887581000016
Issuing Agency: GS1
Commercial Distribution End Date: October 02, 2035
Device Count: 1
Labeler D-U-N-S® Number*: 595128042 *Terms of Use

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

What MRI safety information does the labeling contain?	MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MTP	Antibody To Htlv-1, Elisa

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: cdbd4c55-b1f5-46d5-8f5e-6f08a946da35
Public Version Date: February 24, 2021
Public Version Number: 3
DI Record Publish Date: March 11, 2015