FDA UDI Not in Commercial Distribution 🇺🇸 United States

CAROLINA LIQUID CHEMISTRIES CORP.® PHOSPHORUS REAGENT KIT BL218

DI: 00817302024111 · Model: AU-240 · CAROLINA LIQUID CHEMISTRIES CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
CAROLINA LIQUID CHEMISTRIES CORP.® PHOSPHORUS REAGENT KIT BL218
Primary DI
00817302024111
Version / Model
AU-240
Catalog Number
AU-240
Company Name
CAROLINA LIQUID CHEMISTRIES CORPORATION
Labeler DUNS
962385787
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-08-19
Public Version
2
Public Version Date
2022-10-17
Public Version Status
Update
Public Device Record Key
1f581aff-23b5-4f5f-b8b8-0bde84f8f1d9
Distribution End Date
2022-10-13

Device Description

Alkaline Aminotransferase (ALT) (GPT) Reagent

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
Yes
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
CKA NADH OXIDATION/NAD REDUCTION, ALT/SGPT

GMDN Terms

Code Name
52923 Alanine aminotransferase (ALT) IVD, kit, enzyme spectrophotometry

Identifiers

Type ID
Primary 00817302024111

Customer Contacts

Device Sizes

Type Value Unit Text
Total Volume 8 Milliliter
Total Volume 44 Milliliter
Device Size Text, specify Kit contains 3 R1 bottles and 3 R2 bottles

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
2 – 8 Degrees Celsius