GERMAINE LABORATORIES, INC

Address:11030 Wye Drive,SAN ANTONIO,TX,78217,US

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Filters

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

Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) (JIR) (4) Refractometer For Clinical Use (JRE) (4) Blood, Occult, Colorimetric, In Urine (JIO) (4) Automated Urinalysis System (KQO) (4) Method, Enzymatic, Glucose (Urinary, Non-Quantitative) (JIL) (4) Dye-Indicator, Ph (Urinary, Non-Quant.) (CEN) (3) Antigens, All Groups, Streptococcus Spp. (GTY) (2) Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) (JMT) (2) Multi-Analyte Controls, All Kinds (Assayed) (JJY) (2) Nitroprusside, Ketones (Urinary, Non-Quant.) (JIN) (2) Reagent, Occult Blood (KHE) (2) Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) (CDM) (1) Test, Urine Leukocyte (LJX) (1) Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) (JJB) (1)

Premarket Exempt

No Yes

Clear

AIMSTRIP US-4 - 00695684544003 Catalog Number :

Device Description : Dipstick reagent strips for the qualitative detection of the following : Glucose Dipstick reagent strips for the qualitative detection of the following : Glucose, Protein, pH and Blood in Urine.

Device Class :

Duns Number: 176458115

Premarket Exempt : No

Product Code : JIO, JIL, CEN, JIR, JRE, KQO

Prescription Use : Yes

Device Count : 100

AIMSTRIP US-5 - 00695684551001 Catalog Number :

Device Description : Dipstick reagent strips for the qualitative detection of the following : Blood, Dipstick reagent strips for the qualitative detection of the following : Blood, Glucose, Protein, Ketone and pH in Urine.

Device Class :

Duns Number: 176458115

Premarket Exempt : No

Product Code : KQO, JRE, JIR, JIO, JIN, JIL, CEN

Prescription Use : Yes

Device Count : 100

AIMSTRIP US-5B - 00695684552008 Catalog Number :

Device Class :

Duns Number: 176458115

Premarket Exempt : No

Product Code : LJX, KQO, JRE, JMT, JIR, JIO, JIL

Prescription Use : Yes

Device Count : 100

AIMSTRIP US-9 - 00695684591007 Catalog Number :

Device Class :

Duns Number: 176458115

Premarket Exempt : No

Product Code : KQO, JRE, JMT, JJB, JIR, JIO, JIN, JIL, CEN, CDM

Prescription Use : Yes

Device Count : 100

HCG URINE CONTROLS - 00695684710026 Catalog Number :

Device Description : Bi-level, For use with qualitative hCG urine tests.

Device Class :

Duns Number: 176458115

Premarket Exempt : No

Product Code : JJY

Prescription Use : Yes

Device Count : 2

HCG SERUM CONTROLS - 00695684710033 Catalog Number :

Device Description : Tri-level, For use with qualitative hCG serum tests.

Device Class :

Duns Number: 176458115

Premarket Exempt : No

Product Code : JJY

Prescription Use : Yes

Device Count : 3

STREPAIM - 00695684730253 Catalog Number :

Device Description : A rapid dipstick test for the qualitative detection of group A streptococcal ant A rapid dipstick test for the qualitative detection of group A streptococcal antigen from throat swabs.

Device Class :

Duns Number: 176458115

Premarket Exempt : No

Product Code : GTY

Prescription Use : No

Device Count : 25

STREPAIM - 00695684730406 Catalog Number :

Device Class :

Duns Number: 176458115

Premarket Exempt : No

Product Code : GTY

Prescription Use : No

Device Count : 40

IFOB COLLECTION BOTTLES - 00695684740085 Catalog Number :

Device Description : IFOB Collection Bottles, to be used with IFOB kit

Device Class :

Duns Number: 176458115

Premarket Exempt : No

Product Code : KHE

Prescription Use : Yes

Device Count : 30

COMPLIANCE GOLD iFOB PATIENT COLLECTION KITS FC - 00695684740146 Catalog Number :

Device Description : Patient collection kits for IFOB kit, for Full Compliance version

Device Class :

Duns Number: 176458115

Premarket Exempt : No

Product Code : KHE

Prescription Use : Yes

Device Count : 15

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