FDA.reportPublic FDA data

VITROS

Primary DI
20758750034298
Brand
VITROS
Company
ORTHO CLINICAL DIAGNOSTICS
Model
6199334
Catalog number
6199334
Device description
VITROS Immunodiagnostic Products Total B HCG II Reagent Pack
Published
2024-09-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233581000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233581000VITROS Immunodiagnostic Products Total ß-hCG II Reagent PackOrtho Clinical Diagnostics2024-05-08DHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20758750034298PackageGS130In Commercial Distribution
10758750034291PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2075875003429820758750034298
1075875003429110758750034291

GMDN Terms#

Term, Definition table
TermDefinition
Total human chorionic gonadotropin IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total human chorionic gonadotropin (HCG), which includes a combination of intact HCG, nicked HCG, alpha-HCG subunits, and beta-HCG subunits, in a clinical specimen using a chemiluminescent immunoassay method. It is used to aid detection of pregnancy, or as a predictive indicator of adverse pregnancy outcomes (e.g., miscarriage) and/or trisomy 21 (Down syndrome).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not freeze
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
215865786
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
10758750033287VITROS619773561977352020-05-16
10758750033294VITROS619557561955752020-05-16
10758750032891VITROS690004069000402025-12-30
10758750033522VITROS691223269122322025-12-30
10758750033539VITROS691223369122332025-12-30
10758750008322VITROS100940610094062020-04-08
10758750002061VITROS680215668021562015-12-22
10758750002504VITROS680230168023012015-12-22
10758750035366VITROS619945461994542025-05-20
10758750035373VITROS619945561994552025-05-20
10758750035380VITROS619945661994562025-05-20
20758750035363VITROS619945461994542025-05-20
20758750035370VITROS619945561994552025-05-20
20758750035387VITROS619945661994562025-05-20
10758750000203VITROS189683618968362016-08-26
10758750002801VITROS680245468024542014-10-22
10758750035465VITROS617444261744422023-11-22
10758750034420VITROS619996161999612021-11-08
10758750033355VITROS619991961999192021-03-22
10758750033362VITROS619992061999202021-03-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380740106003ARCHITECTABBOTT IRELANDDHA2025-12-12
20612479280124McKessonMCKESSON MEDICAL-SURGICAL INC.DHA2025-12-10
10612479280172McKessonMCKESSON MEDICAL-SURGICAL INC.DHA2025-12-10
00380740215712AlinityABBOTT LABORATORIESDHA2025-10-08
20612479279715McKessonMCKESSON MEDICAL-SURGICAL INC.DHA2025-09-10
10758750034291VITROSORTHO 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
04987270235232Lumipulse G BHCG Immunoreaction CartridgesFUJIREBIO INC.DHA2023-02-01
15099590744380Access Total BhCG (5th IS)Beckman Coulter, Inc.DHA2023-01-06
08806388243310Multi-unit Angled AbutmentMegagen Implant Co. LtdDHA2021-11-17
07613336169216Elecsys HCG Test SystemRoche Diagnostics GmbHDHA2021-09-24
07613336169223Elecsys HCG Test SystemRoche Diagnostics GmbHDHA2021-09-24
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
00816870020570Free B-hCG XR AccuBind ELISA Test System - 96 WellsMONOBIND, INC.DHA2019-02-11
00816870020587Free B-hCG XR AccuBind ELISA Test System - 192 WellsMONOBIND, INC.DHA2019-02-11
00816870020921hCG AccuBind ELISA Test System - 96 WellsMONOBIND, INC.DHA2019-02-11
00816870020938Monobind AccuBind hCG ELISA Kit - 192 WellsMONOBIND, INC.DHA2019-02-11
00816870020945hCG Extended Range AccuBind ELISA Test System - 96 WellsMONOBIND, INC.DHA2019-02-11
00816870020952hCG Extended Range AccuBind ELISA Test System - 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