FDA.reportPublic FDA data

Glucoquant GlucoseHK

Primary DI
04015630991853
Brand
Glucoquant GlucoseHK
Company
Roche Diagnostics GmbH
Model
11876899216
Catalog number
11876899216
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
CFRHEXOKINASE, GLUCOSE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CFRHexokinase, GlucoseClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K812303000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K812303000GLUCOSE-HK SYSTEM PACK TESTBoehringer Mannheim Corp.1981-09-01CFR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630991853PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630991853040156309918534015630991853

GMDN Terms#

Term, Definition table
TermDefinition
Glucose IVD, kit, spectrophotometryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of glucose in a clinical specimen, using a spectrophotometry method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315028860
Device count
1
Lot or batch
true
Expiration date on label
true

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Primary DI, Brand, Company table
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