FDA.reportPublic FDA data

H100Plus Hemolytic Agent L

Primary DI
06980120080356
Brand
H100Plus Hemolytic Agent L
Company
Shenzhen Lifotronic Technology Co.,Ltd.
Model
250 mL
Published
2026-11-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
LCPAssay, Glycosylated Hemoglobin
PDJHemoglobin A1c Test System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LCPAssay, Glycosylated HemoglobinHematology2
PDJHemoglobin A1c Test SystemClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K260468000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K260468000H100Plus Hemoglobin Testing SystemShenzhen Lifotronic Technology Co., Ltd.2026-10-02PDJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06980120080356PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06980120080356069801200803566980120080356

Regulatory Flags#

DUNS number
530798732
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
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
06978139074008H100Plus HbA1c Eluent A800 mL2026-11-03
06978139074015H100Plus HbA1c Eluent A1600 mL2026-11-03
06978139074022H100Plus HbA1c Eluent B800 mL2026-11-03
06978139074039H100Plus HbA1c Eluent C800 mL2026-11-03
06978139074046H100Plus HbA1c CalibratorLevel 1: 1×0.1mL, Level 2: 1×0.1mL2026-11-03
06978139074053H100Plus HbA1c Control MaterialLevel 1: 1×0.1mL, Level 2: 1×0.1mL2026-11-03
06978139074060H100Plus HbA1c Control MaterialLevel 1: 1×0.5mL, Level 2: 1×0.5mL2026-11-03
06978139074077H100Plus Hemolytic Agent L2500 mL2026-11-03
06978139074084H100Plus Hemolytic Agent L5000 mL2026-11-03
06978139074091Probe Rinse Solution5 mL*52026-11-03
06978139074381H100Plus Hemoglobin Analyzer(HPLC)H100Plus2026-11-03
06978139074398H100Plus Hemoglobin Chromatographic Column(HPLC)H100Plus 50002026-11-03
06978139074404H100Plus Hemoglobin Chromatographic Column(HPLC)H100Plus 100002026-11-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06978139074008H100Plus HbA1c Eluent AShenzhen Lifotronic Technology Co.,Ltd.LCP2026-11-03
06978139074008H100Plus HbA1c Eluent AShenzhen Lifotronic Technology Co.,Ltd.PDJ2026-11-03
06978139074015H100Plus HbA1c Eluent AShenzhen Lifotronic Technology Co.,Ltd.PDJ2026-11-03
06978139074015H100Plus HbA1c Eluent AShenzhen Lifotronic Technology Co.,Ltd.LCP2026-11-03
06978139074022H100Plus HbA1c Eluent BShenzhen Lifotronic Technology Co.,Ltd.PDJ2026-11-03
06978139074022H100Plus HbA1c Eluent BShenzhen Lifotronic Technology Co.,Ltd.LCP2026-11-03
06978139074039H100Plus HbA1c Eluent CShenzhen Lifotronic Technology Co.,Ltd.PDJ2026-11-03
06978139074039H100Plus HbA1c Eluent CShenzhen Lifotronic Technology Co.,Ltd.LCP2026-11-03
06978139074046H100Plus HbA1c CalibratorShenzhen Lifotronic Technology Co.,Ltd.PDJ2026-11-03
06978139074046H100Plus HbA1c CalibratorShenzhen Lifotronic Technology Co.,Ltd.LCP2026-11-03
06978139074053H100Plus HbA1c Control MaterialShenzhen Lifotronic Technology Co.,Ltd.PDJ2026-11-03
06978139074053H100Plus HbA1c Control MaterialShenzhen Lifotronic Technology Co.,Ltd.LCP2026-11-03
06978139074060H100Plus HbA1c Control MaterialShenzhen Lifotronic Technology Co.,Ltd.PDJ2026-11-03
06978139074060H100Plus HbA1c Control MaterialShenzhen Lifotronic Technology Co.,Ltd.LCP2026-11-03
06978139074077H100Plus Hemolytic Agent LShenzhen Lifotronic Technology Co.,Ltd.LCP2026-11-03
06978139074077H100Plus Hemolytic Agent LShenzhen Lifotronic Technology Co.,Ltd.PDJ2026-11-03
06978139074084H100Plus Hemolytic Agent LShenzhen Lifotronic Technology Co.,Ltd.PDJ2026-11-03
06978139074084H100Plus Hemolytic Agent LShenzhen Lifotronic Technology Co.,Ltd.LCP2026-11-03
06978139074381H100Plus Hemoglobin Analyzer(HPLC)Shenzhen Lifotronic Technology Co.,Ltd.LCP2026-11-03
06978139074381H100Plus Hemoglobin Analyzer(HPLC)Shenzhen Lifotronic Technology Co.,Ltd.PDJ2026-11-03
06978139074398H100Plus Hemoglobin Chromatographic Column(HPLC)Shenzhen Lifotronic Technology Co.,Ltd.PDJ2026-11-03
06978139074398H100Plus Hemoglobin Chromatographic Column(HPLC)Shenzhen Lifotronic Technology Co.,Ltd.LCP2026-11-03
06978139074404H100Plus Hemoglobin Chromatographic Column(HPLC)Shenzhen Lifotronic Technology Co.,Ltd.PDJ2026-11-03
06978139074404H100Plus Hemoglobin Chromatographic Column(HPLC)Shenzhen Lifotronic Technology Co.,Ltd.LCP2026-11-03
00380740208622ARCHITECTAbbott GmbHPDJ2026-05-15
00380740208622ARCHITECTAbbott GmbHLCP2026-05-15
00380740208639AlinityAbbott GmbHPDJ2026-05-15
00380740208639AlinityAbbott GmbHLCP2026-05-15
00860004423409QvinQurasense, Inc.LCP2026-05-08
00860004423492QvinQurasense, Inc.LCP2026-05-08