FDA.reportPublic FDA data

AIMSTEP PREGNANCY

Primary DI
00695684970321
Brand
AIMSTEP PREGNANCY
Company
GERMAINE LABORATORIES, INC
Model
97032
Device description
Urine cassette test. For the rapid qualitative determination of human Chorionic Gonadotropin (hCG) in urine.
Published
2016-06-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
JHIVisual, Pregnancy Hcg, Prescription Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JHIVisual, Pregnancy Hcg, Prescription UseClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00695684970321PrimaryGS10
00695684970017Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00695684970321006956849703216956849703210695684970321
00695684970017006956849700176956849700170695684970017

GMDN Terms#

Term, Definition table
TermDefinition
Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of total human chorionic gonadotropin (HCG), which may include intact HCG, nicked HCG, free alpha-HCG subunits and/or free beta-HCG subunits, in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
176458115
Device count
2000
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
10695684423381AimScreen Fentanyl423382024-04-01
00695684893019Pregcolor Plus893012023-08-09
00695684971014Pregcolor Premium 97101PCP2023-08-09
00695684410117SAFECUP III MULTIDRUG 11410112022-08-17
00695684444310SAFECUP III 13 PANEL 444332022-08-17
00695684754075Mosie Baby Ovulation Test754072019-10-21
00695684957018Mosie Baby Pregnancy Test957012019-10-21
06956847540756Mosie Baby Ovulation Test754072019-10-21
06956848940166Mosie Baby Pregnancy Test957012019-10-21
00695684511005AIMSTRIP 10-SG511002016-04-21
00695684511111AIMSTRIP US-11511112016-04-27
00695684544003AIMSTRIP US-4544002016-04-27
00695684551001AIMSTRIP US-5551002016-04-27
00695684552008AIMSTRIP US-5B552002016-04-27
00695684591007AIMSTRIP US-9591002016-04-27
00695684131128KETONE SERUM CONTROLS131122019-02-06
00695684730253STREPAIM730252019-02-06
00695684010003BRUCELLA ABORTUS ANTIGEN10002016-04-12
00695684010027BRUCELLA MELITENSIS ANTIGEN10022016-04-21
00695684011000BRUCELLA ABORTUS ANTISERUM11002016-04-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
80810164510101Atida hCG Pregnancy Rapid Combo TestACESO LABORATORIES INC.JHI2026-03-23
00816862027723HORMONElife™WONDFO USA CO., LTD.JHI2026-01-15
00850082766000QMedix™Diagnostic Automation, Inc.JHI2025-12-24
00816862028119HORMONElife™WONDFO USA CO., LTD.JHI2025-12-15
10612479280134McKessonMCKESSON MEDICAL-SURGICAL INC.JHI2025-12-10
10612479280158McKessonMCKESSON MEDICAL-SURGICAL INC.JHI2025-12-10
10612479279855MckessonMCKESSON MEDICAL-SURGICAL INC.JHI2025-08-14
10612479279862McKessonMCKESSON MEDICAL-SURGICAL INC.JHI2025-08-14
56952062778160HCG Home Use Pregnancy Test Midstream (Colloidal Gold)ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTDJHI2025-02-12
10673486002454Teco Diagnostics One-Step Urine/Serum Combo Pregnancy Card TestTECO DIAGNOSTICSJHI2024-12-19
00850054026651QMedix™Diagnostic Automation, Inc.JHI2024-06-25
10197344024995MedlineMEDLINE INDUSTRIES, INC.JHI2024-03-11
10673486002409Teco Diagnostics One-Step Urine/Serum Combo Pregnancy Card TestTECO DIAGNOSTICSJHI2024-01-16
10673486002379TECO DIAGNOSTICS ONE-STEP PREGNANCY DIPSTICK TESTTECO DIAGNOSTICSJHI2023-10-26
10816862023784PreviewWONDFO USA CO., LTD.JHI2023-08-03
10816862023807WondfoWONDFO USA CO., LTD.JHI2023-08-03
00850051158096PrabadinPrabadin CorpJHI2023-06-08
00850035206164ProovMfb Fertility, Inc.JHI2023-05-17
00850035206126ProovMfb Fertility, Inc.JHI2023-03-28
00850035206003ProovMfb Fertility, Inc.JHI2023-03-24
15099590776886ICON 25 hCGBeckman Coulter, Inc.JHI2022-10-21
10888277703575MedlineMEDLINE INDUSTRIES, INC.JHI2022-06-08
10885380181153CARDINAL HEALTHCardinal Health 200, LLCJHI2022-02-22
10885380181191CARDINAL HEALTHCardinal Health 200, LLCJHI2022-02-22
10885380181177CARDINAL HEALTHCardinal Health 200, LLCJHI2022-01-11
10885380181184CARDINAL HEALTHCardinal Health 200, LLCJHI2022-01-11
10894175000081OneStepDiagnostic Automation, Inc.JHI2021-08-11
00817415020987DealmedDEALMED MEDICAL SUPPLIES LLCJHI2021-06-11
00083059104851EZ-hCG Urine Pregnancy TestBIOMERICA, INC.JHI2020-07-01
00630414294254Atellica IM ThCGSiemens Healthcare Diagnostics Inc.JHI2020-05-31