CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument
Sebia
SEBIA
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1063666 | 3001595416 | SEBIA, INC. | 1 | Y | 2026-01-01 | 400-1705 CORPORATE DR. NORCROSS GA US 30093 |
PMN#
FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2
Sebia
FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2
Sebia
HYDRASHIFT 2/4 Isatuximab
Sebia
CAPI 3 Immunotyping, Capillarys 3 Tera
Sebia
HYDRASHIFT 2/4 Daratumumab
Sebia
CAPI 3 HEMOGLOBIN(E)
SEBIA
CAPILLARYS Hb A1c
Sebia
HYDRASHIFT 2/4 Daratumumab, Daratumumab Control
Sebia
CAPI 3 Hb A1c
Sebia
CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2)
SEBIA
CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL
Sebia
MINICAP Immunotyping Using The MINICAP And The MINICAP FLEX-PIERCING
SEBIA
MINICAP HB A1C, MINICAP FLEX-PIERCING, HB A1C CAPILLARYS CONTROLS, HBA1C CAPILLARYS CALIBRATORS
SEBIA
CAPILLARYS IMMUNOTYPING, CAPILLARYS 2 INSTRUMENT, IT/IF CONTROL, CAPILLARYS 2 FLEX PIERCING INSTRUMENT
SEBIA
CAPILLARYS HEMOGLOBIN HBA1C CAPILLARYS 2 FLEX PIERCING CAPILLARYS HBA1C CONTROLS CAPILLARYS HBA1C C
SEBIA
CAPILLARYS HEMOGLOBIN, CAPILLARYS FLEX PIERCING SYSTEM
SEBIA
SEBIA CAPILLARYS HEMOGLOBIN(E) WITH CAPILLARYS 2
SEBIA
IT/IF CONTROL
SEBIA
GELSCAN, MODEL 1206
SEBIA
CAPILLARYS NEONAT HB (PN 2006)
SEBIA
CAPILLARYS IMMUNOTYPING, MODEL 2100
Sebia
MINICAP IMMUNOTYPING, MODEL: 2300
SEBIA
MINICAP HEMOGLOBIN(E) KIT, MODEL 2207, 2227
SEBIA
CAPILLARYS URINE
SEBIA
HYDRAGEL 18 A1AT ISOFOCUSING KIT (PN 4356)
SEBIA
CAPILLARY'S HEMOGLOBIN(E) (PN 2007)
SEBIA
CAPILLARY'S IMMUNOTYPING (PN 2100)
Sebia, Inc.
NORMAL AND HYPERGAMMA CONTROL SERUM
SEBIA
HYDRAGEL ISO-PAL K20 (PN 3022); HYDRAGEL 7 ISO-PAL (PN 4112); HYDRAGEL 15 ISO-PAL (PN 4132)
SEBIA
HYRAGEL ISO-LDH KIT/HYDRAGEL 15 ISO-LDH KIT
SEBIA
HYDRAGEL PROTEIN(E) KIT
SEBIA
GUDID#
ANTISERA AND FIXATIVE SOLUTION FOR HYDRAGEL 4 & 9 IF MAXI-KIT (DYNAMIC MASK) - 4316
2026-01-09
ANTISERA AND FIXATIVE SOLUTION FOR HYDRAGEL 9 BENCE JONES MAXI-KIT(DYNAMIC MASK) - 4318
2026-01-09
HYDRAGEL 9 IF MAXI-KIT WITHOUT ANTISERUM (DYNAMIC MASK) - 4387
2026-01-09
ANTISERA AND FIXATIVE SOLUTION FOR HYDRAGEL 4 IF MAXI-KIT (STANDARD MASK) - 4816
2026-01-09
ANTISERA AND FIXATIVE SOLUTION FOR HYDRAGEL 9 IF MAXI-KIT (STANDARD MASK) - 4817
2026-01-09
ANTISERA AND FIXATIVE SOLUTION FOR HYDRAGEL 9 BENCE JONESMAXI-KIT(STANDARD MASK) - ANTISERA AND FIXATIVE SOLUTION FOR HYDRAGEL 9 BENCE JONES MAXI-KIT (STANDARD MASK)
2026-01-09
ANTISERUM AND FIXATIVE SOLUTION FOR HYDRAGEL 12 IF Penta MAXI-KIT(STANDARD MASK) - ANTISERUM AND FIXATIVE SOLUTION FOR HYDRAGEL 12 IF Penta MAXI-KIT (STANDARD MASK)
2026-01-09
ANTISERUM AND FIXATIVE SOLUTION FOR HYDRAGEL 12 IF Penta MAXI-KIT (DYNAMIC MASK) - 4319
2026-01-08
HYDRAGEL 4 IF MAXI-KIT WITHOUT ANTISERUM (DYNAMIC MASK) - 4386
2026-01-08
HYDRAGEL 9 BENCE JONES MAXI-KIT WITHOUT ANTISERUM (DYNAMIC MASK) - 4388
2026-01-08
HYDRAGEL 12 IF Penta MAXI-KIT WITHOUT ANTISERUM (DYNAMIC MASK) - 4389
2026-01-08
HYDRAGEL 4 IF MAXI-KIT WITHOUT ANTISERUM (STANDARD MASK) - 4886
2026-01-08
HYDRAGEL 9 IF MAXI-KIT WITHOUT ANTISERUM (STANDARD MASK) - 4887
2026-01-08
HYDRAGEL 9 BENCE JONES MAXI-KIT WITHOUT ANTISERUM (STANDARD MASK) - 4888
2026-01-08
HYDRAGEL 12 IF Penta MAXI-KIT WITHOUT ANTISERUM (STANDARD MASK) - 4889
2026-01-08
CAPILLARYS 3 DBS - INSTRUMENT
2024-04-30
CAPI 3 NEONAT Hb - 2506
2024-04-30
CAPI 3 NEONAT HEMOLYSING SOLUTION - 2563
2024-04-30
CAPILLARYS 3 DBS MICROPLATES - MICROPLATES ARE AN ACCESSORY _PLASTIC PLATES
2024-04-30
CAPI 3 NEONAT Hb AF Control - 4757
2024-04-30
Hb AFSC Control - 4792
2024-04-30
ANTISERA CAPI 3 IT (10) - 2601
2023-11-29
Sample Diluent CAPI 3 IT (10) - 2602
2023-11-29
CAPILLARYS CDT - CARBOHYDRATE DEF TRANSFERRING BY CE
2022-12-08
CAPILLARYS CDT MAXI KIT - CARBOHYDRATE DEF TRANSFERRIN BY CE MAXI KIT
2022-12-08
MINICAP CDT - CARBOHYDRATE DEF TRANSFERRIN BY MINICAP CE
2022-12-08
MINICAP CDT MAXI KIT - CARBOHYDRATE DEF TRANSFERRIN BY CE MINICAP
2022-12-08
CAPI 3 CDT - CARBOHYDRATE DEF TRANSFERRIN BY CE
2022-12-08
Hb AFSA2 CONTROL (1) - 4758
2023-07-27
Hb AFSA2 CONTROL (5) - 4759
2023-07-27
FLC Kappa - 5102
2023-03-31
FLC Lambda - 5103
2023-03-31
FLC Control Level 1 - 5112
2023-03-31
FLC Control Level 2 - 5113
2023-03-31
HYDRAGEL 15 LIPOPROTEIN(E) - 4134
2022-12-28
HYDRAGEL 30 LIPOPROTEIN(E) - 4138
2022-12-28
CAPILLARYS/MINICAP WASH SOLUTION (2) - CAPILLARYS /MINICAP WASH SOLUTION IS USED IN CONJUNCTION WITH 510K CLEARED KITS. THE SOLUTION WAS PART OF THE PERFORMANCE TESTING INCLUDED WITH K082085.
2022-12-16
CAPICLEAN - CAPICLEAN IS USED IN CONJUNCTION WITH 510K CLEARED KITS. THE SOLUTION WAS PART OF THE PERFORMANCE TESTING INCLUDED WITH K082085
2022-12-16
CLEAN PROTECT - 2059
2022-12-16
CAPILLARYS 3 CAPICLEAN - CAPILLARYS 3 CAPICLEAN IS USED IN CONJUNCTION WITH 510K CLEARED KITS. THE SOLUTION WAS PART OF THE PERFORMANCE TESTING INCLUDED WITH K161928.
2022-12-16