DEVICE: First Check (00643281801128)

Device Identifier (DI) Information

First Check
THC Test- 2 pack
Not in Commercial Distribution

FIRST CHECK DIAGNOSTIC CORP.
00643281801128
GS1
March 31, 2021
2
945331317 *Terms of Use
No description.
CLOSE

Device Characteristics

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

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
55550 Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of cannabinoids and/or cannabinoid metabolites (i.e., natural, synthetic) in a clinical specimen, using an enzyme immunoassay (EIA) method.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
NFW Test, Cannabinoid, Over The Counter
LDJ Enzyme Immunoassay, Cannabinoids
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K052115 000
No CLOSE

Sterilization

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

Storage and Handling

[?]
Storage and Handling
Handling Environment Temperature: between 40 and 86 Degrees Fahrenheit
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

5fe118b0-b46f-4b63-a751-b1924eccdd3a
November 28, 2022
4
September 06, 2019
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: 00643281990402 CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
1-888-788-5716
info@firstcheckfamily.com
CLOSE