STERLING DIAGNOSTICS, INC.

Matched from indexed company URL: STERLING DIAGNOSTICS INC

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1831796	1831796	STERLING DIAGNOSTICS, INC.	1	N	2020-04-25	36645 Metro Ct Sterling Heights MI US 48312

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
33382	1653149819	K914039	SODIUM REAGENT SET	CEI	1991-10-31
33382	1170072149	K861713	SERUM POTASSIUM REAGENT SET	CEJ	1986-05-23
33382	1762933968	K860667	ASPARTATE AMINOTRANSFERASE (AST/SGOT) REAGENT SET	CIT	1986-04-03
33382	1177245141	K860478	SERUM IRON & IRON BINDING REAGENT SET	JIY	1986-03-14
33382	1127321532	K860475	HEMOGLOBIN REAGENT SET	KHG	1986-03-03
33382	1918946355	K860420	SICKLE CELL REAGENT SET	GHM	1986-02-24
33382	1612697761	K860418	CREATININE REAGENT SET	CGX	1986-02-11
33382	1642929074	K860351	ALKALINE PHOSPHATASE REAGENT SET	CIO	1986-02-11
33382	1443207793	K860341	TOTAL PROTEIN (BIURET) REAGENT SET	CEK	1986-02-11
33382	1075855307	K860340	SERUM ALBUMIN (BCG) REAGENT SET	CIX	1986-02-19
33382	1051003544	K860216	SGOT (AST) REAGENT SET	CIQ	1986-04-03
33382	1595202879	K860214	TOTAL BILIRUBIN REAGENT SET	CIG	1986-03-17
33382	1595200136	K860154	BUN (ENZYMATIC BERTHELOT) REAGENT SET	CDL	1986-02-06
33382	1883512405	K860142	URIC ACID REAGENT SET (COLORIMETRIC)	LFQ	1986-02-11
33382	1773731235	K860096	CPK REAGENT SET (COLORIMETRIC)	CGS	1986-02-11
33382	1737525490	K854335	GLUCOSE REAGENT SET (GOD/TRINDER)	CGA	1985-11-22
33382	1692136536	K851504	VDRL CARBON ANTIGEN TEST S900500, S900250 & S90010	GMP	1985-08-19
33382	1489936623	K801422	SANDARE LYOPHILIZED GLYCOHEMOGLOBIN CLS.	LCP	1980-07-08
33382	1359774142
33382	1493181965
33382	1587087232
33382	1976426644
33382	2039564452

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
CEI	1	1991-10-31
CEJ	1	1986-05-23
CIT	1	1986-04-03
CIQ	1	1986-04-03
CIG	1	1986-03-17
JIY	1	1986-03-14
KHG	1	1986-03-03
GHM	1	1986-02-24
CIX	1	1986-02-19
CGX	1	1986-02-11
CEK	1	1986-02-11
CIO	1	1986-02-11
LFQ	1	1986-02-11
CGS	1	1986-02-11
CDL	1	1986-02-06
CGA	1	1985-11-22
GMP	1	1985-08-19
LCP	1	1980-07-08

PMN#

MICROPROTEIN REAGENT SET

1993-01-21

STERLING DIAGNOSTICS, INC.

TRIGLYCERIDES REAGENT SET

1991-11-07

STERLING DIAGNOSTICS, INC.

SODIUM REAGENT SET

1991-10-31

STERLING DIAGNOSTICS, INC.

PHOSPHOLIPID REAGENT SET

1991-10-30

STERLING DIAGNOSTICS, INC.

LACTATE DEHYDROGENASE (LDH) REAGENT SET (UV RATE)

1986-07-29

STERLING DIAGNOSTICS, INC.

VANILMANDELIC ACID (VMA) REAGENT SET

1986-07-07

STERLING DIAGNOSTICS, INC.

ALKALINE PHOSPHATASE (PNPP RATE) REAGENT SET

1986-07-01

STERLING DIAGNOSTICS, INC.

UREA NITROGEN (GLDH) REAGENT SET (UV)

1986-07-01

STERLING DIAGNOSTICS, INC.

ALT (SGPT) REAGENT SET (UV RATE)

1986-06-25

STERLING DIAGNOSTICS, INC.

HYDROXYBUTYRATE DEHYDROGENASE (HBD) REAGENT SET

1986-06-16

STERLING DIAGNOSTICS, INC.

SERUM POTASSIUM REAGENT SET

1986-05-23

STERLING DIAGNOSTICS, INC.

SALICYLATE REAGENT SET

1986-05-23

STERLING DIAGNOSTICS, INC.

GLUCOSE (HEXOKINASE) REAGENT SET

1986-04-24

STERLING DIAGNOSTICS, INC.

SERUM CHOLINESTERASE REAGENT SET

1986-04-24

STERLING DIAGNOSTICS, INC.

ASPARTATE AMINOTRANSFERASE (AST/SGOT) REAGENT SET

1986-04-03

STERLING DIAGNOSTICS, INC.

SGOT (AST) REAGENT SET

1986-04-03

STERLING DIAGNOSTICS, INC.

SGPT (ALT) REAGENT SET (COLORIMETRIC)

1986-04-03

STERLING DIAGNOSTICS, INC.

URIC ACID REAGNET SET (TRINDER)

1986-04-03

STERLING DIAGNOSTICS, INC.

GAMMA GLUTAMYL TRANSPEPTIDASE (GGTP) REAGENT SET

1986-03-17

STERLING DIAGNOSTICS, INC.

TOTAL BILIRUBIN REAGENT SET

1986-03-17

STERLING DIAGNOSTICS, INC.

INORGANIC PHOSPHORUS REAGENT SET

1986-03-14

STERLING DIAGNOSTICS, INC.

SERUM LIPASE REAGENT SET (TURBIDIMETRIC)

1986-03-14

STERLING DIAGNOSTICS, INC.

SERUM IRON & IRON BINDING REAGENT SET

1986-03-14

STERLING DIAGNOSTICS, INC.

ACID PHOSPHATASE REAGENT SET

1986-03-05

STERLING DIAGNOSTICS, INC.

HEMOGLOBIN REAGENT SET

1986-03-03

STERLING DIAGNOSTICS, INC.

AMYLASE REAGENT SET (MODIFIED CARAWAY)

1986-02-28

STERLING DIAGNOSTICS, INC.

LACTATE DEHYDROGENASE (LDH) REAGENT SET

1986-02-28

STERLING DIAGNOSTICS, INC.

SICKLE CELL REAGENT SET

1986-02-24

STERLING DIAGNOSTICS, INC.

ENZYNATIC TRIGLYCERIDES REAGENT SET

1986-02-19

STERLING DIAGNOSTICS, INC.

SERUM ALBUMIN (BCG) REAGENT SET

1986-02-19

STERLING DIAGNOSTICS, INC.

CALCIUM (CPC) REAGENT SET

1986-02-11

STERLING DIAGNOSTICS, INC.

URIC ACID REAGENT SET (COLORIMETRIC)

1986-02-11

STERLING DIAGNOSTICS, INC.

UREA NITROGEN REAGENT SET

1986-02-11

STERLING DIAGNOSTICS, INC.

TOTAL PROTEIN (BIURET) REAGENT SET

1986-02-11

STERLING DIAGNOSTICS, INC.

MAGNESIUM REAGENT SET

1986-02-11

STERLING DIAGNOSTICS, INC.

CREATININE REAGENT SET

1986-02-11

STERLING DIAGNOSTICS, INC.

CPK REAGENT SET (COLORIMETRIC)

1986-02-11

STERLING DIAGNOSTICS, INC.

ALKALINE PHOSPHATASE REAGENT SET

1986-02-11

STERLING DIAGNOSTICS, INC.

BUN (ENZYMATIC BERTHELOT) REAGENT SET

1986-02-06

STERLING DIAGNOSTICS, INC.

TOTAL CHOLESTEROL REAGENT SET

1986-01-28

STERLING DIAGNOSTICS, INC.

41 records. Showing 1-40. Next

GUDID#

ALBUMIN RGT SET - 2110-0

STERLING DIAGNOSTICS INC

2016-09-14

CREATININE/ ENDPOINT - CREATININE/ENDPOINT

STERLING DIAGNOSTICS INC

2016-09-14

UREA NITROGEN (BERTHELOT) - UREA NITROGEN/COLOR (BERTHELOT)

STERLING DIAGNOSTICS INC

2016-09-14

UREA NITROGEN (BERTHELOT) - 2290-0

STERLING DIAGNOSTICS INC

2016-09-14

ENZYMATIC CHOLESTEROL - ENZYMATIC CHOLESTEROL (TRINDER/COD-CEH)

STERLING DIAGNOSTICS INC

2016-09-14

ENZYMATIC CHOLESTEROL - ENZYMATIC CHOLESTEROL (TRINDER/COD-CEH)

STERLING DIAGNOSTICS INC

2016-09-14

HDL CHOLESTEROL - HDL CHOLESTEROL (PEG METHOD)

STERLING DIAGNOSTICS INC

2016-09-14

CPK / COLORIMETRIC - CREATINE PHOSPHOKINASE (CPK) COLORIMETRIC

STERLING DIAGNOSTICS INC

2016-09-14

ENZYMATIC GLUCOSE - GLUCOSE ENZYMATIC TRINDER

STERLING DIAGNOSTICS INC

2016-09-14

GLYCOHEMOGLOBIN - 2193-0

STERLING DIAGNOSTICS INC

2016-09-14

SERUM IRON/IBC - SERUM IRON/IBC COLORIMETRIC

STERLING DIAGNOSTICS INC

2016-09-14

SGOT COLORIMETRIC - SGOT/AST COLORIMETRIC

STERLING DIAGNOSTICS INC

2016-09-14

SGPT Colorimetric - SGPT/ALT COLORIMETRIC

STERLING DIAGNOSTICS INC

2016-09-14

TRIGLYCERIDES - GPO - TRIGLYCERIDES -GPO TEST

STERLING DIAGNOSTICS INC

2016-09-14

ENZYMATIC URIC ACID - URIC ACID ENZYMATIC URICASE TRINDER

STERLING DIAGNOSTICS INC

2016-09-14

ALKALINE PHOSPHATASE - ALKALINE PHOSPHATASE (COLORIMETRIC TMP)

STERLING DIAGNOSTICS INC

2016-09-14

SICKLE CELL - SICKLE CELL (QUALITATIVE Hb-S TEST)

STERLING DIAGNOSTICS INC

2016-09-14

T. PROTEIN RGT SET - TOTAL PROTEIN RGT SET

STERLING DIAGNOSTICS INC

2016-09-14

SODIUM KIT - SODIUM KIT (COLORIMETRIC METHOD)

STERLING DIAGNOSTICS INC

2016-09-14

POTASSIUM - POTASSIUM (TURBIDIMETRIC)

STERLING DIAGNOSTICS INC

2016-09-14

SUPER SENSITIVE CHOLESTEROL - SUPER SENSITIVE CHOLESTEROL (TRINDER/COD-CEH)

STERLING DIAGNOSTICS INC

2016-09-14

TOTAL AND DIRECT BILIRUBIN - TOTAL AND DIRECT BILIRUBIN (MODIFIED MALLOY-EVELYN)

STERLING DIAGNOSTICS INC

2016-09-14

RPR CARD TEST - S168-0

STERLING DIAGNOSTICS INC

2016-09-14

TOTAL BILIRUBIN - TOTAL BILIRUBIN (MODIFIED MALLOY-EVELYN)

STERLING DIAGNOSTICS INC

2016-09-14