FDA.reportPublic FDA data

AIMSTRIP HEMOGLOBIN STARTER KIT 200

Primary DI
00695684782009
Brand
AIMSTRIP HEMOGLOBIN STARTER KIT 200
Company
GERMAINE LABORATORIES, INC
Model
78200
Device description
For testing hemoglobin in whole blood
Published
2016-05-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
GIGHemoglobinometer
KHGWhole Blood Hemoglobin Determination

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GIGHemoglobinometerHematology2
KHGWhole Blood Hemoglobin DeterminationHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00695684782009PrimaryGS10
00695684782000Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00695684782009006956847820096956847820090695684782009
00695684782000006956847820006956847820000695684782000

GMDN Terms#

Term, Definition table
TermDefinition
Total haemoglobin (totHb) IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative determination of total haemoglobin (totHb) in a clinical specimen, using an enzyme spectrophotometry method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
176458115
Device count
200
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00695684744250AimStep Flu A&B Test Kit744252026-05-11
00695684773014AimStrip Tandem Lipid Profile and glucose measuring systemILM-0001A2020-03-13
00695684775506AimStrip Tandem blood glucose test stripsILM-0001A2020-03-13
00695684773106AimStrip Tandem Total Cholesterol Test StripsILM-0001A2020-03-13
00695684773120AimStrip Tandem Total Cholesterol Control SolutionILM-0001A2020-03-13
00695684774103AimStrip Tandem Total Triglycerides Test StripsILM-0001A2020-03-13
00695684774127AimStrip Tandem Total Triglycerides Control SolutionILM-0001A2020-03-13
00695684775124AimStrip Tandem Glucose control solutionILM-0001A2020-03-13
00695684423384AimScreen Fentanyl423382024-04-01
10695684423381AimScreen Fentanyl423382024-04-01
00695684893019Pregcolor Plus893012023-08-09
00695684971014Pregcolor Premium 97101PCP2023-08-09
00695684957018Mosie Baby Pregnancy Test957012019-10-21
00695684885304AIMSTRIP PREGNANCY885302016-04-11
00695684888305AIMSTRIP COMBO PREGNANCY888302016-04-27
00695684891015AccuHome Pregnancy Test891012016-04-11
00695684891022AccuHome Pregnancy Test891022016-04-11
00695684891404AccuHome Pregnancy Test891402016-04-11
00695684970253AIMSTEP PREGNANCY970252016-04-11
00695684970307AIMSTEP PREGNANCY970302016-04-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048534000840CleanerEKF-diagnostic GmbHKHG2022-12-21
04048534002189Add Pack Hemo Control DMEKF-diagnostic GmbHKHG2022-12-21
M9308460905110Life InstrumentsLife Instrument CorporationGIG2022-02-25
M93084609051S0Life Instruments Life Instrument CorporationGIG2022-02-25
04048534000031Hemo Control Hemoglobin MicrocuvetteEKF-diagnostic GmbHKHG2021-05-10
04048534002028Hemo ControlEKF-diagnostic GmbHKHG2021-05-10
00817869020052Hemoglobin AFSC ControlANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00817869020069Hemoglobin NAFSC ControlANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00817869020076Hemoglobin AF ControlANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00817869020083Hemoglobin AC ControlANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00817869020090Hemoglobin AS ControlANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00817869020106Hemoglobin AC Control PowderANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00817869020113Hemoglobin F Normal ControlANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00817869020120Hemoglobin F Abnormal ControlANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00817869020137Hemoglobin G6PDH Normal ControlANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00817869020144Hemoglobin G6PDH Deficient ControlANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00817869020151Hemoglobin G6PDH Intermediate ControlANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00817869020168Hemoglobin Total Normal ControlANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00817869020175Hemoglobin Total Linearity ControlANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00817869020182Hemoglobin A2 Normal ControlANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00817869020199Hemoglobin A2 Elevated ControlANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00817869020205Hemoglobin AE ControlANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00817869020212Hemoglobin FAS ControlANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00817869020229Hemoglobin AD ControlANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00817869020236HemoglobinAG Philadelphia ControlANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00657498000144STAT-Site M Hgb Analyzer PackSTANBIO LABORATORY, L.P.KHG2016-09-24
00657498000151STAT-Site M Hgb CardsSTANBIO LABORATORY, L.P.KHG2016-09-24
00657498000175STAT-Site M Hgb Code KeySTANBIO LABORATORY, L.P.KHG2016-09-24
05391516743136Trinity BiotechCLARK LABORATORIES, INC.KHG2016-09-19
05391516743143Trinity BiotechCLARK LABORATORIES, INC.KHG2016-09-19