DEVICE: Anti Human IgA FITC (B1761022)

Device Identifier (DI) Information

Anti Human IgA FITC
1
In Commercial Distribution
102202
KENT LABORATORIES INC
B1761022
HIBCC

1
093642254 *Terms of Use
Fluorescein conjugated polyclonal goat antiserum to Human IgA
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Total immunoglobulin A (IgA total) IVD, antibody One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of total immunoglobulin A (IgA total) in a clinical specimen.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
CZN Iga, Fitc, Antigen, Antiserum, Control
CLOSE

FDA Premarket Submission

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

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between -20 and 6 Degrees Celsius
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

6340877d-b8c9-4a99-9573-9cfffc4a6d0a
March 29, 2018
2
September 21, 2016
CLOSE

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
CLOSE

Secondary DI

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

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
360-398-8641
donald@kentlabs.com
CLOSE