AccessGUDID - DEVICE: Alinity mp (00884999048973)

GUDID

Device Identifier (DI) Information

Brand Name: Alinity mp
Version or Model: 09N65-007
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 09N65-007
Company Name: ABBOTT MOLECULAR INC.

Primary DI Number: 00884999048973
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 878263359 *Terms of Use

Device Description: Alinity mp Reagent Addition Assembly

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):	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?
62011	Instrument/analyser specimen/reagent container carrier IVD	A device intended to hold a specimen/reagent container (e.g., test tube, tissue specimen petri dish, microplate, cuvette) on board an in vitro diagnostic laboratory instrument or analyser (e.g., PCR machine, spectrophotometric plate reader, biopsy specimen analyser, automated liquid handling station). It may be in the form of a removable tray (excludes immunoassay vehicle trays), holder, shuttle, rack/rack base, slotted case, or other format suitable to be handled and loaded into the parent device by the operator or via an automated process. This is a reusable device.	Active	false
66828	Barcode reader IVD	An electrically-powered, photoelectric device designed to read and interpret labelling barcodes on in vitro diagnostic clinical specimens, or consumables (e.g., reagents, controls, buffers, diluent). It is typically a hand-held device which is connected to a computer, or a dedicated in vitro diagnostic instrument/analyser system. This device may be capable of storing the read data and downloading it to other data systems.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JQW	STATION, PIPETTING AND DILUTING, FOR CLINICAL USE

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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
Special Storage Condition, Specify: Ambient (15-30C)
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: a5474599-2220-417a-a77a-84a47061c2f3
Public Version Date: June 05, 2025
Public Version Number: 1
DI Record Publish Date: May 28, 2025

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: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

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

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES