CAROLINA LIQUID CHEMISTRIES CORPORATION

Address:510 W Central Ave Ste C,Brea,CA,92821,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED) (JJX) (7) BROMCRESOL GREEN DYE-BINDING, ALBUMIN (CIX) (3) CALIBRATOR, SECONDARY (JIT) (3) LIPOPROTEIN, LOW-DENSITY, ANTIGEN, ANTISERUM, CONTROL (DFC) (3) SYSTEM, TEST, VITAMIN D (MRG) (2) URINARY HOMOCYSTINE (NONQUANTITATIVE) TEST SYSTEM (LPS) (2)

Premarket Exempt

No Yes

Clear

CAROLINA LIQUID CHEMISTRIES CORP.® HCY LEVEL 3 CONTROL KIT PART# CC053 - 00817302020113 Catalog Number : CC053

Device Description : HCY (Homocysteine) Level 3 control 6 x 5 mL

Device Class : 1

Duns Number: 962385787

Premarket Exempt : No

Product Code : JJX, LPS

Prescription Use : Yes

Device Count : 1

CAROLINA LIQUID CHEMISTRIES CORP.™ HCY HOMOCYSTEINE REAGENT CC202 - 00817302020120 Catalog Number : CC202

Device Description : HCY (Homocysteine) w/ cal 2 x 60 tests

Device Class : 1

Duns Number: 962385787

Premarket Exempt : No

Product Code : LPS, JJX

Prescription Use : Yes

Device Count : 1

CAROLINA LIQUID CHEMISTRIES CORP.® LP(a) RGT. KIT BL-204 - 00817302020137 Catalog Number : BL204

Device Description : Lp(a) (Lipoprotein (a) 2 x 130 tests

Device Class : 1

Duns Number: 962385787

Premarket Exempt : No

Product Code : DFC, JIT, JJX

Prescription Use : Yes

Device Count : 1

CAROLINA LIQUID CHEMISTRIES CORP.® LP(a)-D RGT. KIT AU-204-D - 00817302020144 Catalog Number : AU-204-D

Device Description : Lp(a) (Lipoprotein (a) 3 x 400 tests

Device Class : 1

Duns Number: 962385787

Premarket Exempt : No

Product Code : DFC, JJX, JIT

Prescription Use : Yes

Device Count : 1

CAROLINA LIQUID CHEMISTRIES CORP.™ Lp(a)-d LIPOPROTEIN A CC204-100-D - 00817302020151 Catalog Number : CC204-100-D

Device Description : Lp(a) (Lipoprotein (a) 2 x 60 tests

Device Class : 1

Duns Number: 962385787

Premarket Exempt : No

Product Code : DFC, JIT, JJX

Prescription Use : Yes

Device Count : 1

CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 Vitamin D RGT KIT Product No. ST500 - 00817302020168 Catalog Number : ST501

Device Description : Vitamin D-direct control 2 x 2 mL (2 lev)

Device Class : 1

Duns Number: 962385787

Premarket Exempt : No

Product Code : JJX, MRG

Prescription Use : Yes

Device Count : 1

CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 Vitamin D CONTROL SET - 00817302020175 Catalog Number : ST500

Device Description : Vitamin D-direct w/ cal 1 x 100 tests

Device Class : 1

Duns Number: 962385787

Premarket Exempt : No

Product Code : MRG, JJX

Prescription Use : Yes

Device Count : 1

CAROLINA LIQUID CHEMISTRIES CORP.® ALB RGT.KIT BL-224 - 00817302020182 Catalog Number : BL-224.

Device Description : ALB (Albumin) 3 X 160 tests

Device Class : 2

Duns Number: 962385787

Premarket Exempt : No

Product Code : CIX

Prescription Use : Yes

Device Count : 1

CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 ALBUMIN REAGENT KIT Product No. ST224 - 00817302020199 Catalog Number : ST224

Device Description : ALB (Albumin) 4 x 150 tests

Device Class : 2

Duns Number: 962385787

Premarket Exempt : No

Product Code : CIX

Prescription Use : Yes

Device Count : 1

CAROLINA LIQUID CHEMISTRIES CORP.® ALB RGT. KIT AU-224 - 00817302020205 Catalog Number : AU-224

Device Description : ALB (Albumin) 3 x 250 tests

Device Class : 2

Duns Number: 962385787

Premarket Exempt : No

Product Code : CIX

Prescription Use : Yes

Device Count : 1

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