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Amniotic Fluid Protein Immunoassay

Page Type
Product Code
Definition
To detect specified amniotic fluid proteins in cervicovaginal samples
Physical State
dipstick or cassette
Technical Method
Detects specified amniotic fluid proteins
Target Area
Cervicovaginal fluid samples
Regulation Medical Specialty
Chemistry
Review Panel
Chemistry
Submission Type
510(K)
Device Classification
Class 1
Regulation Number
862.1550
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 862.1550 Urinary pH (nonquantitative) test system

§ 862.1550 Urinary pH (nonquantitative) test system.

(a) Identification. A urinary pH (nonquantitative) test system is a device intended to estimate the pH of urine. Estimations of pH are used to evaluate the acidity or alkalinity of urine as it relates to numerous renal and metabolic disorders and in the monitoring of patients with certain diets.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000]

Amniotic Fluid Protein Immunoassay

Page Type
Product Code
Definition
To detect specified amniotic fluid proteins in cervicovaginal samples
Physical State
dipstick or cassette
Technical Method
Detects specified amniotic fluid proteins
Target Area
Cervicovaginal fluid samples
Regulation Medical Specialty
Chemistry
Review Panel
Chemistry
Submission Type
510(K)
Device Classification
Class 1
Regulation Number
862.1550
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 862.1550 Urinary pH (nonquantitative) test system

§ 862.1550 Urinary pH (nonquantitative) test system.

(a) Identification. A urinary pH (nonquantitative) test system is a device intended to estimate the pH of urine. Estimations of pH are used to evaluate the acidity or alkalinity of urine as it relates to numerous renal and metabolic disorders and in the monitoring of patients with certain diets.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000]