FDA.report

CAROLINA LIQUID CHEMISTRIES CORP.® ALP RGT.KIT AU-206

Primary DI
00817302020243
Brand
CAROLINA LIQUID CHEMISTRIES CORP.® ALP RGT.KIT AU-206
Company
CAROLINA LIQUID CHEMISTRIES CORPORATION
Model
AU-206
Catalog number
AU-206
Device description
ALP (Alkaline Phosphatase) 3 x 250 tests
Published
2016-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
CJENITROPHENYLPHOSPHATE, ALKALINE PHOSPHATASE OR ISOENZYMES

Product Code Classifications

CodeDeviceSpecialtyClass
CJENitrophenylphosphate, Alkaline Phosphatase Or IsoenzymesClinical Chemistry2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00817302020243PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00817302020243008173020202438173020202430817302020243

GMDN Terms

TermDefinition
Alkaline phosphatase (ALP) isoenzyme IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of one or multiple alkaline phosphatase (ALP) isoenzymes in a clinical specimen, using an enzyme spectrophotometry method.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Total Volume8Milliliter
Total Volume57Milliliter

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00After opening, the reagent is stable for 14 days when stored at 2 to 8°
Special Storage Condition, Specify00Unopened reagents are stable to expiration date when stored at 2 to 8°C
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)471-7272ContactSales@CarolinaChemistries.com

Regulatory Flags

DUNS number
962385787
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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