FDA.reportPublic FDA data

AccuHome Pregnancy Test

Primary DI
00695684891015
Brand
AccuHome Pregnancy Test
Company
GERMAINE LABORATORIES, INC
Model
89101
Device description
Urine Midstream, Rapid qualitative test to detect the presence of hCG in urine. Designed for self testing (home). Results within 3 minutes.
Published
2016-04-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
DHASystem, Test, Human Chorionic Gonadotropin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DHASystem, Test, Human Chorionic GonadotropinClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00695684891015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00695684891015006956848910156956848910150695684891015

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
1
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
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
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
00380740106003ARCHITECTABBOTT IRELANDDHA2025-12-12
10612479280172McKessonMCKESSON MEDICAL-SURGICAL INC.DHA2025-12-10
20758750034298VITROSORTHO CLINICAL DIAGNOSTICSDHA2024-09-18
07613336217535Elecsys HCG+ betaRoche Diagnostics GmbHDHA2024-06-03
06947145578039MAGLUMI 2000 HCG/beta-HCGShenzhen New Industries Biomedical Engineering Co., Ltd.DHA2024-05-11
06947145578046MAGLUMI 2000 HCG/beta-HCGShenzhen New Industries Biomedical Engineering Co., Ltd.DHA2024-05-11
06925912718703iFlash-HCGShenzhen YHLO Biotech Co., Ltd.DHA2024-01-30
00695684893019Pregcolor PlusGERMAINE LABORATORIES, INCDHA2023-08-09
00695684971014Pregcolor Premium GERMAINE LABORATORIES, INCDHA2023-08-09
07613336169216Elecsys HCG Test SystemRoche Diagnostics GmbHDHA2021-09-24
07613336169223Elecsys HCG Test SystemRoche Diagnostics GmbHDHA2021-09-24
04987270235232Lumipulse G BHCG Immunoreaction CartridgesFUJIREBIO INC.DHA2019-11-04
00695684957018Mosie Baby Pregnancy TestGERMAINE LABORATORIES, INCDHA2019-10-21
06956848940166Mosie Baby Pregnancy TestGERMAINE LABORATORIES, INCDHA2019-10-21
00380740160623AlinityABBOTT IRELANDDHA2019-04-10
00816862021639PreviewWONDFO USA CO., LTD.DHA2019-03-06
00816870020570Monobind AccuBind Free B-hCG XR ELISA Kit - 96 WellsMONOBIND, INC.DHA2019-02-11
00816870020587Monobind AccuBind Free B-hCG XR ELISA Kit - 192 WellsMONOBIND, INC.DHA2019-02-11
00816870020921Monobind AccuBind hCG ELISA Kit - 96 WellsMONOBIND, INC.DHA2019-02-11
00816870020938Monobind AccuBind hCG ELISA Kit - 192 WellsMONOBIND, INC.DHA2019-02-11
00816870020945Monobind AccuBind hCG Extended Range ELISA Kit - 96 WellsMONOBIND, INC.DHA2019-02-11
00816870020952Monobind AccuBind hCG Extended Range ELISA Kit - 192 WellsMONOBIND, INC.DHA2019-02-11
00816870022253Monobind AccuLite Free B-hCG XR CLIA Kit - 96 WellsMONOBIND, INC.DHA2019-02-11
00816870022260Monobind AccuLite Free B-hCG XR CLIA Kit - 192 WellsMONOBIND, INC.DHA2019-02-11
00816870022581Monobind AccuLite hCG CLIA Kit - 96 WellsMONOBIND, INC.DHA2019-02-11
00816870022598Monobind AccuLite hCG CLIA Kit - 192 WellsMONOBIND, INC.DHA2019-02-11
00816870022604Monobind AccuLite hCG Extended Range CLIA Kit - 96 WellsMONOBIND, INC.DHA2019-02-11
00816870022611Monobind AccuLite hCG Extended Range CLIA Kit - 192 WellsMONOBIND, INC.DHA2019-02-11
00380740160616AlinityABBOTT IRELANDDHA2018-05-31
04015630939732Elecsys HCG+betaRoche Diagnostics GmbHDHA2017-04-21