AccessGUDID - DEVICE: IMMCO DIAGNOSTICS (00845714003318)

GUDID

Device Identifier (DI) Information

Brand Name: IMMCO DIAGNOSTICS
Version or Model: 2200
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2200
Company Name: IMMCO DIAGNOSTICS, INC.

Primary DI Number: 00845714003318
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079935300 *Terms of Use

Device Description: Negative 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?
57777	Immunohistochemistry negative control (normal animal serum) IVD	A material in the form of normal animal serum intended to be used in place of a primary antibody as a negative control to verify the performance of an immunohistochemistry assay performed on biological tissues or clinical specimens.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DBL	Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
LKJ	Antinuclear Antibody, Antigen, Control
MOB	Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
DHN	Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K060157	000
K883883	000
K883915	000
K883949	000
K884400	000
K891098	000
K891099	000
K912551	000
K913360	000
K982898	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: .5 ml

Device Record Status

Public Device Record Key: 9f53b873-052f-41de-ac6e-ada531464379
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 23, 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

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

FDA TOOLS & RESOURCES