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Address: 5700 Old Brim Road, Midland, Georgia 31820, USA
https://www.path-tec.com |
Send Inquiry |
Phone: +1-(706)-569-6368
FDA Registration: 3007871198
Products: General Specimen Collection & Transport Kits, Specimen Collection Device (FDA Code:
LIO), Phlebotomy Blood Collection Kit (FDA Code:
OFM), Blood Alcohol Kit (Excludes Hiv Testing) (FDA Code:
OIC), Urine Transport Kit (Excludes Hiv Testing) (FDA Code:
OHZ), Urine Cytology Kits (FDA Code:
OKY), ...
Path-Tec is a leading provider of specimen management products and services. We help laboratories effectively collect and transport samples through effective product design, distribution, tracking and
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Address: 13500 Linden Avenue North, Bitter Lake, Washington 98133, USA
www.usbiotek.com |
Send Inquiry |
Phone: +1-(206)-3651256
Products: ELISA Test Kits, Urinary Growth Hormone, Asthma Management Kit, Assessment Equipment, IgE (Immunoglobulin E) Serum, Automated Blood Grouping and Antibody Test System (FDA Code:
KSZ), B. Dermatitidis Antigen (FDA Code:
JWW), ...
Us Biotek Laboratories provides medical laboratory testing methods. Our laboratory services include IgG, IgE & IgA antibody assessment panels, serum or whole blood from finger stick IgA antibody asses
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Address: 25 Yanina Street, Yelatma, Ryazan 391351, Russian Federation
Phone: +7-(303)-6463715
FDA Registration: 3007075140
Products: Medical Instrument Ultrasonic Cleaner (FDA Code:
FLG), Powered Heating Pad (FDA Code:
IRT), Non-Sterile Specimen Container (FDA Code:
NNI), Blood And Urine Collection Kit (Excludes Hiv Testing) (FDA Code:
OIB), Urine Collection Kit (Excludes Hiv Testing) (FDA Code:
OIE), Urine Transport Kit (Excludes Hiv Testing) (FDA Code:
OHZ), ...
Yelatma Instrument-Making Enterprise deals with cleaners, collection kits & containers. We provide bedpan, blood & urine collection kits, medical instrument ultrasonic cleaners, non-sterile specimen c
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FDA Code / Regulation: OHZ / 864.3250 A specimen transport and storage container, which may be empty or prefilled, is a device intended to contain biological specimens, body waste, or body exudate during storage and transport in order that the matter contained therein can be destroyed or used effectively for diagnostic examination. If prefilled, the device contains a fixative solution or other general purpose reagent to preserve the condition of a biological specimen added to the container. This section does not apply to specimen transport and storage containers that are intended for use as part of an over-the-counter test sample collection system for drugs of abuse testing.
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 864.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180 of this chapter, with respect to general requirements concerning records, and 820.198 of this chapter, with respect to complaint files.