AccessGUDID - DEVICE: IMMCO DIAGNOSTICS (00845714001895)

GUDID

Device Identifier (DI) Information

Brand Name: IMMCO DIAGNOSTICS
Version or Model: 2211
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2211
Company Name: IMMCO DIAGNOSTICS, INC.

Primary DI Number: 00845714001895
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079935300 *Terms of Use

Device Description: ASMA Positive Control

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?
54834	Multiple liver disease-associated antibody IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative screening for one or multiple antibodies associated with liver disease in a clinical specimen. The assayed antibodies may include autoimmune antibodies directed at liver-kidney microsome 1 protein (anti-LKM1), smooth muscle (anti-SMA), F-Actin, soluble liver antigen (SLA), Sp-100 protein, glycoprotein-210 (gp210), lamin B receptor (LBR) and also liver cytosol specific antibody type 1 (anti-LC1) and/or antimitochondrial antibodies (AMA).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DBL	Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K883915	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
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: ml

Device Record Status

Public Device Record Key: 21d9317b-edc3-4743-9cfb-5194580d7852
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: November 15, 2016

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: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 1-800-537-8378
Email: info@immco.com

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