Blood Uric Acid Monitoring System

Primary DI
16971404130925
Brand
Blood Uric Acid Monitoring System
Company
e-Linkcare Meditech Co., Ltd
Model
PM900C
Device description
Blood uric acid Monitoring Meter with Blood Uric Acid Test Strips are intended for use for the quantitative measurement of uric acid in fresh capillary whole blood or venous whole blood
Published
2021-12-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
LFQAcid, Uric, Acid Reduction Of Ferric Ion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LFQAcid, Uric, Acid Reduction Of Ferric IonClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16971404130925PackageGS11In Commercial Distribution
26971404130922PackageGS124In Commercial Distribution
26971404131349PackageGS11In Commercial Distribution
36971404131346PackageGS124In Commercial Distribution
06971404130928PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697140413092516971404130925
2697140413092226971404130922
2697140413134926971404131349
3697140413134636971404131346
06971404130928069714041309286971404130928

GMDN Terms#

Term, Definition table
TermDefinition
Uric acid monitoring system IVD, home-useA collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, test strips, and/or other associated disposable materials intended to be used for the quantitative measurement of uric acid in a whole blood clinical specimen; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. It is used to monitor the effectiveness of uric acid control in various disorders (e.g., renal failure, gout, leukaemia), and in patients receiving cytotoxic chemotherapy.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
540481217
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06971404130911Blood Ketone Monitoring SystemPM900B2021-12-17
06971404131581Blood Ketone Control solution(level 1)CM2112022-05-17
06971404131598Blood Ketone Control solution(level 2)CM2112022-05-17
06971404131604Blood Ketone Control solution(level 3)CM2112022-05-17
06971404131611Uric Acid Control solution(level 1)CM3112022-05-17
06971404131628Uric Acid Control solution(level 2)CM3112022-05-17
06971404130928Blood Uric Acid Monitoring SystemPM900C2021-12-17
16971404130949Blood Uric Acid Test StripsSM4112021-12-17
16971404131199Blood Ketone Test StripsSM3112021-12-17
16971404130918Blood Ketone Monitoring SystemPM900B2021-12-17
26971404130946Blood Uric Acid Test StripsSM4112021-12-17
26971404131196Blood Ketone Test StripsSM3112021-12-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816042014475FORAFORA CARE INC.LFQ2023-10-31
00850014861353HeartsCare C1 URIC ACID TEST STRIPS(10PCS/BOX)Hearts Bio, Inc.LFQ2023-08-08
00816042014116FORAFORA CARE INC.LFQ2023-06-26
00816042014192FORAFORA CARE INC.LFQ2023-06-26
00816042014109FORAFORA CARE INC.LFQ2023-06-26
80816042014112FORAFORA CARE INC.LFQ2023-06-26
00816042014185FORAFORA CARE INC.LFQ2023-06-26
80816042014198FORAFORA CARE INC.LFQ2023-06-26
06971404131611Uric Acid Control solution(level 1)e-Linkcare Meditech Co., LtdLFQ2022-05-17
06971404131628Uric Acid Control solution(level 2)e-Linkcare Meditech Co., LtdLFQ2022-05-17
00886338000031UASure II Blood Uric Acid Monitoring SystemAPEX BIOTECHNOLOGY CORP.LFQ2021-12-27
00886338000062UASure II Blood Uric Acid Test Strips 25sAPEX BIOTECHNOLOGY CORP.LFQ2021-12-27
16971404130949Blood Uric Acid Test Stripse-Linkcare Meditech Co., LtdLFQ2021-12-17
06971404130928Blood Uric Acid Monitoring Systeme-Linkcare Meditech Co., LtdLFQ2021-12-17
26971404130946Blood Uric Acid Test Stripse-Linkcare Meditech Co., LtdLFQ2021-12-17
04713648766462UASure Blood Uric Acid Monitoring Meter APEX BIOTECHNOLOGY CORP.LFQ2020-05-11
04713648766479UASure Blood Uric Acid Test StripAPEX BIOTECHNOLOGY CORP.LFQ2020-05-11