FDA.report

POINTE SCIENTIFIC Cholesterol (Liquid)

Primary DI
00811727010841
Brand
POINTE SCIENTIFIC Cholesterol (Liquid)
Company
POINTE SCIENTIFIC, INC.
Model
C7510-1L
Catalog number
C7510-1L
Device description
For the quantitative determination of Total Cholesterol in serum.
Published
2016-08-31
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
CHHEnzymatic Esterase--Oxidase, Cholesterol

Product Code Classifications

CodeDeviceSpecialtyClass
CHHEnzymatic Esterase--Oxidase, CholesterolClinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00811727010841PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00811727010841008117270108418117270108410811727010841

GMDN Terms

TermDefinition
Total cholesterol lipid IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of total cholesterol lipid in a clinical specimen, using an enzyme spectrophotometry method.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
800-445-9853techservice@medtest.com

Regulatory Flags

DUNS number
045623154
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
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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