FDA.reportPublic FDA data

ANKOVO TD-4267 Blood Glucose Test Strips 100PCS

Primary DI
00738629167476
Brand
ANKOVO TD-4267 Blood Glucose Test Strips 100PCS
Company
METENE LIMITED
Model
TD-4267
Published
2020-06-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
CGAGlucose Oxidase, Glucose

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CGAGlucose Oxidase, GlucoseClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K093506000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093506000CLEVER CHOICE AUTO-CODE PRO BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4267Taidoc Technology Corporation2010-04-01CGA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00738629167476PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00738629167476007386291674767386291674760738629167476

GMDN Terms#

Term, Definition table
TermDefinition
Glucose IVD, kit, electrometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of glucose in a clinical specimen, using an electrometry method. It is typically in a strip format (e.g., screen-printed electrode) for use with a dedicated testing device (not included).

Regulatory Flags#

DUNS number
117110707
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850009854001metene BLOOD GLUCOSE MONITORING SYSTEM 100TD-41162026-05-07
00850048540781metene BLOOD GLUCOSE MONITORING SYSTEM 150TD-41162026-05-07
00850063675895metene S BLOOD GLUCOSE MONITORING SYSTEM 50S2026-05-07
00739810207735metene Blood Glucose Test Strips (50pcs*2)TD-41162019-08-19
00850063675956metene S BLOOD GLUCOSE MONITORING SYSTEMS2025-12-24
00850063675680metene S BLOOD GLUCOSE MONITORING SYSTEMS2025-03-31
00850048540798metene BLOOD GLUCOSE MONITORING SYSTEMTD-41162024-12-12
00850009854018metene BLOOD GLUCOSE MONITORING SYSTEMTD-41162022-09-06
00739810205885metene BLOOD GLUCOSE MONITORING SYSTEMTD-41162020-08-20
00738629167469ANKOVO TD-4267 BLOOD GLUCOSE MONITORING SYSTEMTD-42672020-06-10
00739810207742metene BLOOD GLUCOSE MONITORING SYSTEMTD-41162019-08-19

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Primary DI, Brand, Company table
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