AccessGUDID - DEVICE: Axis-Shield Active-B12 (Holotranscobalamin) EIA (05055845400046)

GUDID

Device Identifier (DI) Information

Brand Name: Axis-Shield Active-B12 (Holotranscobalamin) EIA
Version or Model: FMABT100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FMABT100
Company Name: AXIS-SHIELD DIAGNOSTICS LIMITED

Primary DI Number: 05055845400046
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 229062427 *Terms of Use

Device Description: The Axis-Shield Active-B12 (Holotranscobalamin) assay is an enzyme-immunoassay (EIA) for the quantitative determination of holotranscobalamin (HoloTC) in human serum. HoloTC (vitamin B12 bound to transcobalamin) is used as an aid in the diagnosis and treatment of vitamin B12 deficiency.

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:	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?
54458	Vitamin B12 IVD, reagent	A substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of vitamin B12, also known as cobalamin, in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CDD	Radioassay, Vitamin B12

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K121946	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
No Device Sizes

Device Record Status

Public Device Record Key: 63f8bc2a-341b-4295-9462-346baec81c21
Public Version Date: August 05, 2022
Public Version Number: 4
DI Record Publish Date: September 02, 2016