AccessGUDID - DEVICE: ThromboType® (10888234500285)

GUDID

Device Identifier (DI) Information

Brand Name: ThromboType®
Version or Model: THROMBOTYPE
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: THROMBOTYPE
Company Name: IMMUCOR GTI DIAGNOSTICS, INC.

Primary DI Number: 10888234500285
Issuing Agency: GS1
Commercial Distribution End Date: August 15, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 606034197 *Terms of Use

Device Description: ThromboType assay is an assay for the molecular determination of HPA-1 (PlA), HPA-2 (Ko), HPA-3 (Bak), HPA-4 (Pen), HPA-5 (Br), HPA-6 (Ca), and HPA-15 (Gov), using PCR amplification of human genomic DNA.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
56569	Multiple human platelet antigen (HPA) typing IVD, kit, multiplex	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of multiple human platelet antigen (HPA) systems which may include HPA-1, HPA-2, HPA-3, HPA-4, HPA-5 and/or HPA-15 in a clinical specimen, using a multiplex method.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
MYP	Test,Platelet Antibody

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BK050040	0

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: c6ce24bf-c08c-44b8-8f34-2e0ebf4b23f1
Public Version Date: August 15, 2018
Public Version Number: 5
DI Record Publish Date: July 08, 2016