FDA.reportPublic FDA data

MyGlucoHealth® Control Solution 3-Pack

Primary DI
00850081003212
Brand
MyGlucoHealth® Control Solution 3-Pack
Company
ENTRA HEALTH SYSTEMS LLC
Model
MGH-CS3
Device description
Control Solution 3 Pak
Published
2018-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850081003212PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850081003212008500810032128500810032120850081003212

GMDN Terms#

Term, Definition table
TermDefinition
Glucose IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement of glucose in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature46 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
619-684-6232support@entrahealth.com

Regulatory Flags#

DUNS number
826314044
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850081003011MyGlucoHealth Test StripsMGH-TS50-FDA2018-11-19
10852668007016BLE Smart Test StripBLE-SMART-TS50-FDA2019-02-05
00850081003014MyGlucoHealth® Test StripsMGH-TS502017-01-27
00850081003960BLE Smart® Test StripsBLE-TS50-FDA2017-01-27
00850081003007MyGlucoHealth® BT Meter KitMGH-BT12017-01-27
00850081003038MyGlucoHealth LancetsMGH-LCT1002018-09-24
00852668007019BLE Smart® Test StripsBLE-TS50-FDA2017-02-23
00852668007040MyGlucoHealth® Wireless Blood Glucose SystemMGH-CL12017-04-07
00852668007057MyGlucoHealth® Wireless Blood Glucose MeterMGH-CL12017-04-07
00852668007064BLE Smart® Blood Glucose SystemBLE-SMART-METER-FDA2017-01-27
00852668007071BLE Smart® Blood Glucose MeterBLE-SMART-METER2017-01-27
00852668007095MyGlucoHealth® BT MeterMGH-BT12017-01-27
00852668007187BLE Smart® Control SolutionBLE-CS32018-11-20

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Primary DI, Brand, Company table
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05060169697218IDS High Sensitive Estradiol Calibrator SetIMMUNODIAGNOSTIC SYSTEMS LIMITEDJJX2026-06-24
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00195126001045NOVA Lite® IFA Yo (PCA-1) Positive ControlINOVA DIAGNOSTICS, INC.JJX2026-06-09
00850011135877VALIDATELgc Clinical Diagnostics, Inc.JJX2026-06-05
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00021292015398TRUE METRIXTRIVIDIA HEALTH, INC.JJX2025-10-02
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00021292008444TRUE FOCUSTRIVIDIA HEALTH, INC.JJX2021-02-26