DEVICE: CAROLINA LIQUID CHEMISTRIES CORP.® THC50 RGT. KIT ST410A (00817302021776)

Device Identifier (DI) Information

CAROLINA LIQUID CHEMISTRIES CORP.® THC50 RGT. KIT ST410A
ST410A
In Commercial Distribution
ST410A
CAROLINA LIQUID CHEMISTRIES CORPORATION
00817302021776
GS1

1
962385787 *Terms of Use
THC (Cannabinoids) 3 x 375 tests
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
Yes
Yes
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
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FDA Product Code

[?]
Product Code Product Code Name
DLJ CALIBRATORS, DRUG SPECIFIC
LAS DRUG SPECIFIC CONTROL MATERIALS
LDJ ENZYME IMMUNOASSAY, CANNABINOIDS
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Reagent is stable when stored at 2-8° C until expiration date
Storage Environment Temperature: between 2 and 8 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Total Volume: 63 Milliliter
Total Volume: 26 Milliliter
Device Size Text, specify: Kit contains 3 R1 and 3 R2 bottles and 1 package insert
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Device Record Status

abe6378d-77da-4c65-9481-9fc2f3996fb1
November 28, 2022
3
September 01, 2016
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)471-7272
ContactSales@CarolinaChemistries.com
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