Panels › Immunology › Product code MOI · Class 2
System, Test, Immunological, Antigen, Tumor
Regulation 866.6010
0510(k)s in 12 months (28 all time)
0recalls in 12 months (18 all time)
18recalls that name a 510(k)
Top companies in MOI
| Company | 510(k)s | Recalls |
|---|---|---|
| Siemens Healthcare Diagnostics | 3 | 11 |
| Beckman Coulter, Inc. | 3 | 1 |
| Roche Diagnostics | 4 | 0 |
| Abbott Laboratories | 2 | 1 |
| Abbott Laboratories HPD/ADD | 0 | 3 |
| Chiron Diagnostics Corp. | 3 | 0 |
| Bayer Diagnostics Corp. | 2 | 0 |
| Chiron Corp. | 2 | 0 |
| Fujirebio Diagnostics,Inc. | 2 | 0 |
| Abbott Laboratories MPG | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 29, 2022 | Siemens Healthcare Diagnostics, Inc. Dimension Vista LOCI CA 15-3 Flex reagent cartridge. In Vitro Diagnostic for the quantitative measurement of CA 15-3.
Siemens Material Number (SMN)/Ref Catalog Number : 10464344/K6456 Open, Classified |
MOI | K100344 |
| Jul 6, 2021 | Siemens Healthcare Diagnostics, Inc Atellica IM BR 27.29 (BR) Assay 250 Test Kit (Reference)- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the Atellic Open, Classified |
MOI | K982680 |
| Jul 6, 2021 | Siemens Healthcare Diagnostics, Inc Atellica IM BR 27.29 (BR) Assay 250 Test Kit- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the Atellica IM Analyze Open, Classified |
MOI | K982680 |
| Jul 6, 2021 | Siemens Healthcare Diagnostics, Inc Atellica IM BR 27.29 (BR) Assay 50 Test Kit- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the Atellica IM Analyze Open, Classified |
MOI | K982680 |
| May 4, 2018 | Siemens Healthcare Diagnostics, Inc. IMMULITE 2000/IMMULITE 2000 XPi BR-MA (CA15-3) Terminated |
MOI | K013984 |
| May 4, 2018 | Siemens Healthcare Diagnostics, Inc. IMMULITE /IMMULITE 1000 BR-MA (CA15-3) Terminated |
MOI | K013984 |
| Mar 5, 2018 | Tosoh Bioscience Inc ST-AIA PACK 27.29; Part Number: 025202
Assay, Tumor Marker Terminated |
MOI | K010796 |
| Apr 13, 2017 | Beckman Coulter Inc. Access BR Monitor, Part No. 387620 Terminated |
MOI | K033036 K072612 |
| Mar 8, 2017 | Siemens Healthcare Diagnostics, Inc Siemens ADVIA Centaur BR assay
Cat No. 09010686, SMN 10340081 (5-pack/250 tests - REF)
BR Assay for CA 27.29 The ADVIA Centaur BR assay is an in vitro diagnostic test for the quantitative serial de Terminated |
MOI | K982680 |
| Mar 8, 2017 | Siemens Healthcare Diagnostics, Inc Siemens ADVIA Centaur BR assay
Cat No. 03896216, SMN 10334837 (5-pack/250 tests)
BR Assay for CA 27.29 The ADVIA Centaur BR assay is an in vitro diagnostic test for the quantitative serial determin Terminated |
MOI | K982680 |
| Mar 8, 2017 | Siemens Healthcare Diagnostics, Inc Siemens ADVIA Centaur BR assay
Cat No. 02419937, SMN 10333349 (1-pack/50 tests)
BR Assay for CA 27.29 The ADVIA Centaur BR assay is an in vitro diagnostic test for the quantitative serial determina Terminated |
MOI | K982680 |
| Dec 11, 2012 | Siemens Healthcare Diagnostics, Inc Siemens Healthcare BR Assay for CA 27.29
250 Test Kits 03896216
50 Test Kit 02419937
Ref Kit (US only) 10340081
Intended Use The ADVIA Centaur BR assay is an in vitro diagnostic test for the quantit Terminated |
MOI | K982680 |
| Oct 28, 2012 | Siemens Healthcare Diagnostics, Inc Siemens ADVIA Centaur BR Assay: Catalog Number:
US: REF 02419937 (10214722) (50 Tests);
REF 03896216(10334837)(250 Tests) Not
CE Marked; OUS:
REF03204829(10310271)(50 Tests); REF
01157807(1 0314722) ( Terminated |
MOI | K982680 |
| Jul 11, 2007 | Abbott Laboratories AxSYM CA 15-3 Reagent Pack; list 03B42; 100 test pack; an in vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064 Terminated |
MOI | K963926 |
| Jul 18, 2006 | Abbott Laboratories MPG CA 15-3 Controls, list 9C08-10; an In Vitro diagnostic for use with the AxSYM or IMx CA 15-3 reagents, calibrators and instruments; each kit contains 2 bottles with 115D8:DF3 reactive determinants (hu Terminated |
MOI | K963926 K964407 |
| Mar 26, 2003 | Abbott Laboratories HPD/ADD IMx CA 15-3 Reagent Pack, list 6A75-22; this reagent pack contains one 4-mL bottle of Mode 1 Calibrator along with other reagents; Abbott Laboratories, Abbott Park, IL Terminated |
MOI | K964407 |
| Mar 26, 2003 | Abbott Laboratories HPD/ADD CA 15-3 Calibrators, list 9C08-01; the pack contains six 4-mL bottles of 115D8:DF3 reactive determinants prediluted in TRIS buffer with protein stabilizers to yield the following assay values: A - 0 u Terminated |
MOI | K963926 K964407 |
| Mar 26, 2003 | Abbott Laboratories HPD/ADD Abbott AxSYM CA 15-3 Master Calibrator Pack, list 3B42-30; the pack contains two 4-mL bottles, with Master Calibrator 1 having 0 U/mL and Master Calibrator 2 having 60 U/mL; Abbott Laboratories, Abbot Terminated |
MOI | K963926 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.