AccessGUDID - DEVICE: LIFECODES TAQ Polymerase (10888234400134)

GUDID

Device Identifier (DI) Information

Brand Name: LIFECODES TAQ Polymerase
Version or Model: 628075
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 628075
Company Name: IMMUCOR GTI DIAGNOSTICS, INC.

Primary DI Number: 10888234400134
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 606034197 *Terms of Use

Device Description: No description.

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:	No
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?
60092	DNA amplification enzyme reagent IVD	A substance or reactant intended to be used as an enzyme in a molecular assay to facilitate the amplification of target deoxyribonucleic acid (DNA) in a clinical specimen, using a polymerase chain reaction (PCR) technique.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MZI	Test,Qualitative,For Hla,Non-Diagnostic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BK130075	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 -30 and -10 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c8fccf9a-f03a-472b-8262-116b10760311
Public Version Date: July 31, 2023
Public Version Number: 4
DI Record Publish Date: September 15, 2016