AccessGUDID - DEVICE: Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Control Dilution Buffer (10190302019439)

GUDID

Device Identifier (DI) Information

Brand Name: Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Control Dilution Buffer
Version or Model: A57740
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: LIFE TECHNOLOGIES CORPORATION

Primary DI Number: 10190302019439
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 790376870 *Terms of Use

Device Description: Part 3 of 3 of TaqPath™ COVID-19 Diagnostic PCR Kit REF A58505

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?
64747	SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2) in a clinical specimen, using a nucleic acid technique (NAT). This test is used to aid the diagnosis of coronavirus disease (COVID-19) infection.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QQX	Respiratory Specimen Nucleic Acid Sars-Cov-2 Test

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K233453	000

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7ddbe6ef-204b-4378-b95f-06d697d1b934
Public Version Date: February 25, 2025
Public Version Number: 1
DI Record Publish Date: February 17, 2025