AccessGUDID - DEVICE: IntraStain (05700572004387)

GUDID

Device Identifier (DI) Information

Brand Name: IntraStain
Version or Model: K2311
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: AGILENT TECHNOLOGIES SINGAPORE PTE LTD

Primary DI Number: 05700572004387
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 894671143 *Terms of Use

Device Description: IntraStain

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?
61935	Specimen stabilization reagent IVD	A substance or reactant intended to be used alone or in combination with other IVDs to prevent degradation of sensitive analytes (e.g., hormones, proteins, peptides and/or nucleic acids) in a clinical specimen during transportation, storage or processing. A stabilizer is typically a solvent, antioxidant or an enzyme inhibitor.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GGK	PRODUCTS, RED-CELL LYSING PRODUCTS

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
Storage Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 100 Tests

Device Record Status

Public Device Record Key: 0e9b9418-0307-4893-a42d-70f4fe34cd0c
Public Version Date: December 07, 2020
Public Version Number: 2
DI Record Publish Date: September 17, 2020

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: +4544859500
Email: dako.dkregulatory@agilent.com

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