AccessGUDID - DEVICE: Alinity m (00884999047693)

GUDID

Device Identifier (DI) Information

Brand Name: Alinity m
Version or Model: 09N20-002
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 09N20-002
Company Name: ABBOTT MOLECULAR INC.

Primary DI Number: 00884999047693
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 878263359 *Terms of Use

Device Description: Alinity m Ethanol Solution

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:	Yes
Prescription Use (Rx):	No
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?
62689	Molecular grade alcohol IVD	A molecular grade alcohol solution intended to be used for the extraction of nucleic acids (e.g., DNA and/or RNA) from cells in a clinical specimen in preparation for further analysis using a nucleic acid technique (NAT).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MKZ	DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA
QEP	Nucleic acid detection system for non-viral microorganism(s) causing sexually transmitted infections
OUY	Trichomonas vaginalis nucleic acid amplification test system
OOI	real time Nucleic acid amplification system
LSL	DNA-REAGENTS, NEISSERIA

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 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d737f5cb-d3cc-4fe0-8541-0b5ace7710ee
Public Version Date: May 26, 2022
Public Version Number: 1
DI Record Publish Date: May 18, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)553-7042
Email: customerservice@abbottmolecular.com

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