True Metrix GO

TRUE METRIX GO Self Monitoring Blood Glucose Meter - Not For Retail Sale - Meter Only

Registry build 21.09.26
5manufacturers in China registered for this device type
8catalogue numbers in this listing

Who Else Makes It

Concentrated in Tianjin (2), Guangdong (2), Jiangsu (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code LFR
Manufacturer City Province Registered as Device types
Andon Health Co., Ltd. Tianjin Tianjin Contract manufacturer 22
Flextronics Medical Device Manufacturing (Shenzhen) Co., Ltd. Shenzhen Guangdong Contract manufacturer 6
Flextronics Industrial (Shenzhen) Co., Ltd. Shenzhen Guangdong Contract manufacturer 5
Jiangsu NEW Pentastar Medical Products Co., Ltd. Changzhou Jiangsu Exporter 146
Tianjin Empecs Medical Device Co., Ltd. Tianjin Tianjin Contract manufacturer 8

Record

Regulatory record for True Metrix GO
Listed by Trividia Health, Inc., United States
FDA product code LFR
Device type Glucose Dehydrogenase, Glucose
Device class Class 2
Regulation 21 CFR 862.1345
Establishment Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Record published 2018-06-30
Record revised 2025-06-09 (version 6)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Over the counter Yes
Supplied as a kit Yes
Label carries lot or batch number, expiry date, serial number
Storage Handling environment temperature 40 to 86 °F
Packaging Case of 12, case of 40
Distribution end date 2021-05-27

Catalogue Numbers

Catalogue numbers for True Metrix GO
Catalogue number Size Status
TRUE METRIX GO Self Monitoring Blood Glucose Meter In distribution
TRUE METRIX GO Self Monitoring Blood Glucose Meter In distribution
TRUE METRIX GO Self-Monitoring Blood Glucose Meter In distribution
HEB TRUE METRIX GO Self Monitoring Blood Glucose Meter Kit In distribution
TRUE METRIX GO Self Monitoring Blood Glucose Meter In distribution
TRUE METRIX GO Self Monitoring Blood Glucose Meter In distribution
TRUE METRIX GO Self Monitoring Blood Glucose Meter Withdrawn
TRUE METRIX GO Self Monitoring Blood Glucose Meter – NFRS Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
True Metrix Trividia Health, Inc. 15
Contour® Ascensia Diabetes Care US Inc. 10
Fora Fora Care Inc. 9
Contour® Next ONE Ascensia Diabetes Care US Inc. 9
OneTouch Verio Lifescan Europe Gmbh 8
Accu-Chek Aviva Plus Roche Diagnostics Operations 7
McKesson Mckesson Medical-Surgical Inc. 7
Accu-Chek Guide Roche Diagnostics Operations 7
Contour® Next Ascensia Diabetes Care US Inc. 6
Accu-Chek Smart View Roche Diagnostics Operations 6
FreeStyle Lite Abbott Diabetes Care Limited 5
Precision Xtra Abbott Diabetes Care Limited 5

Showing 12 of 124. All products under Glucose Dehydrogenase, Glucose

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer