FDA.report

Pointe Scientific, Inc. Glucose Hex

Primary DI
00811727014160
Brand
Pointe Scientific, Inc. Glucose Hex
Company
POINTE SCIENTIFIC, INC.
Model
13-G7517-120
Catalog number
13-G7517-120
Device description
Reagent for the in vitro quantitative measurement of glucose in serum. 1 x 120 ml
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
CGAGlucose Oxidase, Glucose

Product Code Classifications

CodeDeviceSpecialtyClass
CGAGlucose Oxidase, GlucoseClinical Chemistry2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00811727014160PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00811727014160008117270141608117270141600811727014160

GMDN Terms

TermDefinition
Glucose IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of glucose in a clinical specimen.

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
false
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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