AccessGUDID - DEVICE: Coatest APC Resistance V (08426950060017)

GUDID

Device Identifier (DI) Information

Brand Name: Coatest APC Resistance V
Version or Model: 82 3120 63
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 82 3120 63
Company Name: INSTRUMENTATION LABORATORY COMPANY

Primary DI Number: 08426950060017
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 557223252 *Terms of Use

Device Description: Coatest APC Resistance V

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?
56223	Activated protein C resistant factor V (factor V Leiden) IVD, kit, clotting	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of factor V Leiden, a clotting protein resistant to cleavage by activated protein C, in a clinical specimen using a clotting method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GGW	TEST, TIME, PARTIAL THROMBOPLASTIN

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K963111	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
Special Storage Condition, Specify: The sealed reagents are stable at 2-8°C until the expiry date printed on the label. Avoid contamination of the reagents by microorganisms.
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: ae526c13-9dd1-4a97-b27f-f6b67ef4fed0
Public Version Date: July 13, 2021
Public Version Number: 6
DI Record Publish Date: September 23, 2016